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Quality Operations Manager FT
Dundalk, Leinster
PCI Pharma Services
Posted 2 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This senior operational quality leadership position drives quality excellence across the business unit. The role encompasses comprehensive ownership of quality processes, documentation standards, and regulatory compliance while serving as the primary quality liaison for key customer relationships and critical quality initiatives.
**Key Responsibilities:**
**Quality Leadership & Strategy**
+ Lead the development and execution of quality operations, overseeing all batch manufacturing record generation, and review. Responsible for all production related quality assurance
+ Partner with peer Quality Managers and Quality Systems Manager to drive QA optimization strategies and generate company-wide continuous improvement initiatives
+ Establish cross-functional quality training frameworks and capability development programs across all sites to ensure operational resilience and scalability
**Process Excellence & Compliance**
+ Own the comprehensive governance of quality documentation systems, driving standardization, updates, and maintenance of all quality-related forms and records
+ Authorize and oversee deviation management and investigation protocols, ensuring swift resolution of process and product quality issues while maintaining customer satisfaction
+ Ensure unwavering adherence to GMP standards and customer quality agreements, positioning the organization as a trusted quality partner
**Team Leadership & Development**
+ Provide direction and leadership to the quality operations team (4 direct reports), establishing performance frameworks and operational excellence standards
+ Implement performance management systems that drive accountability and continuous improvement in batch completion metrics and quality indicators
+ Champion a culture of quality excellence through regular coaching, mentoring, and professional development initiatives
**Operational Excellence**
+ Execute systematic GEMBA leadership walks to assess operational standards, drive housekeeping excellence, and ensure comprehensive GMP compliance across all operations
+ Oversee product inspection protocols and quality assessment frameworks, ensuring adherence to specification requirements and proactive issue resolution
+ Direct quality operations across incoming goods receipt and related supply chain touchpoints
**Customer & Stakeholder Management**
+ Lead high-level customer engagement initiatives, representing the organization in quality discussions and driving customer satisfaction through proactive quality partnership
+ Serve as a leader for customer audit processes, ensuring successful outcomes and continuous relationship strengthening
+ Champion process improvement initiatives and operational innovation projects, including transfer of new product introduction initiatives.
**Subject Matter Expertise**
+ Establish and maintain deep technical expertise in packaging and quality processes, serving as the go-to authority for customer and regulatory audit support
+ Drive project leadership and cross-functional collaboration to meet evolving business requirements and organizational objectives
**Essential**
+ Minimum 5 years' experience in Quality for a pharmaceutical company operating to EU GMP standards.
+ 2 years' experience in a leadership or team management role
+ Broad and deep understanding of EudraLex Vol 4, its key chapters and annex's
+ Understanding of serialisation requirements.
+ A flexible and willing attitude
+ Communication skills to interact with internal and external customers at a senior level.
+ Strong Team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, customers and suppliers
+ Design and develop new equipment to help improve line effectiveness.
+ Ability to influence and collaborate at all levels in order to achieve company targets.
+ Ability to represent the company in a professional and highly competent manner.
+ Able to multitask and prioritise activities
+ Ability to work on their own as well as part of a team.
+ Excellent problem-solving skills
**Desirable**
+ Experience in a quality operations department, with responsibility for batch release in support of a Qualified Person Function
+ Experience in hosting regulatory inspections
+ Detailed understanding of both primary and secondary packaging processes.
#LI-MS1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role**
This senior operational quality leadership position drives quality excellence across the business unit. The role encompasses comprehensive ownership of quality processes, documentation standards, and regulatory compliance while serving as the primary quality liaison for key customer relationships and critical quality initiatives.
**Key Responsibilities:**
**Quality Leadership & Strategy**
+ Lead the development and execution of quality operations, overseeing all batch manufacturing record generation, and review. Responsible for all production related quality assurance
+ Partner with peer Quality Managers and Quality Systems Manager to drive QA optimization strategies and generate company-wide continuous improvement initiatives
+ Establish cross-functional quality training frameworks and capability development programs across all sites to ensure operational resilience and scalability
**Process Excellence & Compliance**
+ Own the comprehensive governance of quality documentation systems, driving standardization, updates, and maintenance of all quality-related forms and records
+ Authorize and oversee deviation management and investigation protocols, ensuring swift resolution of process and product quality issues while maintaining customer satisfaction
+ Ensure unwavering adherence to GMP standards and customer quality agreements, positioning the organization as a trusted quality partner
**Team Leadership & Development**
+ Provide direction and leadership to the quality operations team (4 direct reports), establishing performance frameworks and operational excellence standards
+ Implement performance management systems that drive accountability and continuous improvement in batch completion metrics and quality indicators
+ Champion a culture of quality excellence through regular coaching, mentoring, and professional development initiatives
**Operational Excellence**
+ Execute systematic GEMBA leadership walks to assess operational standards, drive housekeeping excellence, and ensure comprehensive GMP compliance across all operations
+ Oversee product inspection protocols and quality assessment frameworks, ensuring adherence to specification requirements and proactive issue resolution
+ Direct quality operations across incoming goods receipt and related supply chain touchpoints
**Customer & Stakeholder Management**
+ Lead high-level customer engagement initiatives, representing the organization in quality discussions and driving customer satisfaction through proactive quality partnership
+ Serve as a leader for customer audit processes, ensuring successful outcomes and continuous relationship strengthening
+ Champion process improvement initiatives and operational innovation projects, including transfer of new product introduction initiatives.
**Subject Matter Expertise**
+ Establish and maintain deep technical expertise in packaging and quality processes, serving as the go-to authority for customer and regulatory audit support
+ Drive project leadership and cross-functional collaboration to meet evolving business requirements and organizational objectives
**Essential**
+ Minimum 5 years' experience in Quality for a pharmaceutical company operating to EU GMP standards.
+ 2 years' experience in a leadership or team management role
+ Broad and deep understanding of EudraLex Vol 4, its key chapters and annex's
+ Understanding of serialisation requirements.
+ A flexible and willing attitude
+ Communication skills to interact with internal and external customers at a senior level.
+ Strong Team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, customers and suppliers
+ Design and develop new equipment to help improve line effectiveness.
+ Ability to influence and collaborate at all levels in order to achieve company targets.
+ Ability to represent the company in a professional and highly competent manner.
+ Able to multitask and prioritise activities
+ Ability to work on their own as well as part of a team.
+ Excellent problem-solving skills
**Desirable**
+ Experience in a quality operations department, with responsibility for batch release in support of a Qualified Person Function
+ Experience in hosting regulatory inspections
+ Detailed understanding of both primary and secondary packaging processes.
#LI-MS1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
0
Accounts Receivable Administrator
Dundalk, Leinster
Graebel Companies, Inc.
Posted 11 days ago
Job Viewed
Job Description
Are you ready to open a world of opportunity in talent mobility? Our clients include some of the largest and most recognized brands in the world. They're innovators and leaders in their industries, making life-enhancing breakthroughs every day. We help them tap into those opportunities by placing their exceptional people where they need to be, anywhere in the world. When it comes to service, we set the bar for exceptional . and then we raise it with fresh ideas, leading tools and innovative approaches, and it's all grounded in our values of truth, love, and integrity. We call it People-first Mobility. We're looking for exceptional people who share those values along with our passion for delivering the highest levels of service. If that sounds like you, and if you're ready for a new career opportunity, we'd like to hear from you! Here's to the world ahead?
The Accounts Receivable Administrator compiles and sorts checks and monies received by Graebel Companies in order to substantiate business transactions and deposit in the banking accounts. Posts payments to customer accounts and assigns miscellaneous revenues to appropriate profit centers. Researches and reconciles all unapplied payments, COD unapplied payments and miscellaneous payments. Works closely with outside customers, GL Accounting, Credit and Collections, Branch personnel and Management to resolve payment discrepancies. This position will be hybrid with 2 days per week in the office.
Principal/ Essential Duties and Responsibilities
+ Researches and identifies unapplied payments. Creates debit memos and reapplies invoices. Sends out refunds when approved. Communicates with credit and collections, branches and managers to resolve issues. Often will need to email or contact customers directly to identify overpayments or unidentified payments. Works closely with collections on researching internal application issues on why certain items were posted or applied a certain way. Will also be called upon to work with customers by email or phone to help understand payment discrepancies.
+ Reconciles the COD statement and unapplied CODs. Contacts GL accountants, managers, and branches for information regarding CODs and unapplied payments. Contacts customers directly and collectors regarding COD unapplied payments. Creates debit memos or applies CODR invoices once created.
+ Assists with training co-workers or new team members for the Cash Department. Helps to answer questions for the department and responds to all cash questions that are sent to Processes the applications being requested through emails. Sources as a resource to all departments for resolving issues and how they will fall out on the companies books where payments &/or adjustments are concerned.
+ Processes all local and foreign wire deposits. Enters the checks into cash receipts. Performs research on international items.
+ Posts daily receipts to customer accounts in order to substantiate business transactions. Identifies customer accounts and invoices to be credited and posts payments made. Investigates reasons for discrepancies and resolves if able.
+ Performs all other related essential duties as assigned or requested.
Required Skills
+ Requires technical knowledge, training and understanding of Cash Accounting principals and processes.
+ One (1) to three (3) years of relevant work experience.
+ Computer experience in data entry, Microsoft Word and Excel
+ Ability to read, analyze and interpret general business periodicals, technical procedures and numerical data.
+ Ability to write simple reports and general business correspondence.
+ Ability to effectively present information and respond to questions from management, customers and employees.
+ Ability to calculate figures and amounts such as discounts interest, commissions, proportions, percentages, area, circumference and volume.
Required Experience
+ Leaving Certificate or equivalent required. May include specialized classes beyond high school.
+ Vocation/Technical/Business School preferred. May include Associate's Degree in Business or Accounting.
+ One (1) to three (3) years of work experience in an Accounting function or in a Cash Transactions role is acceptable in lieu of formal education.
The Accounts Receivable Administrator compiles and sorts checks and monies received by Graebel Companies in order to substantiate business transactions and deposit in the banking accounts. Posts payments to customer accounts and assigns miscellaneous revenues to appropriate profit centers. Researches and reconciles all unapplied payments, COD unapplied payments and miscellaneous payments. Works closely with outside customers, GL Accounting, Credit and Collections, Branch personnel and Management to resolve payment discrepancies. This position will be hybrid with 2 days per week in the office.
Principal/ Essential Duties and Responsibilities
+ Researches and identifies unapplied payments. Creates debit memos and reapplies invoices. Sends out refunds when approved. Communicates with credit and collections, branches and managers to resolve issues. Often will need to email or contact customers directly to identify overpayments or unidentified payments. Works closely with collections on researching internal application issues on why certain items were posted or applied a certain way. Will also be called upon to work with customers by email or phone to help understand payment discrepancies.
+ Reconciles the COD statement and unapplied CODs. Contacts GL accountants, managers, and branches for information regarding CODs and unapplied payments. Contacts customers directly and collectors regarding COD unapplied payments. Creates debit memos or applies CODR invoices once created.
+ Assists with training co-workers or new team members for the Cash Department. Helps to answer questions for the department and responds to all cash questions that are sent to Processes the applications being requested through emails. Sources as a resource to all departments for resolving issues and how they will fall out on the companies books where payments &/or adjustments are concerned.
+ Processes all local and foreign wire deposits. Enters the checks into cash receipts. Performs research on international items.
+ Posts daily receipts to customer accounts in order to substantiate business transactions. Identifies customer accounts and invoices to be credited and posts payments made. Investigates reasons for discrepancies and resolves if able.
+ Performs all other related essential duties as assigned or requested.
Required Skills
+ Requires technical knowledge, training and understanding of Cash Accounting principals and processes.
+ One (1) to three (3) years of relevant work experience.
+ Computer experience in data entry, Microsoft Word and Excel
+ Ability to read, analyze and interpret general business periodicals, technical procedures and numerical data.
+ Ability to write simple reports and general business correspondence.
+ Ability to effectively present information and respond to questions from management, customers and employees.
+ Ability to calculate figures and amounts such as discounts interest, commissions, proportions, percentages, area, circumference and volume.
Required Experience
+ Leaving Certificate or equivalent required. May include specialized classes beyond high school.
+ Vocation/Technical/Business School preferred. May include Associate's Degree in Business or Accounting.
+ One (1) to three (3) years of work experience in an Accounting function or in a Cash Transactions role is acceptable in lieu of formal education.
This advertiser has chosen not to accept applicants from your region.
1
Production Operator - Level 2
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
2
IRE_Production Operator - Level 2
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
3
IRE_Production Operator - Level 2
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
4
IRE_Production Operator - Level 2
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
5
IRE_Production Operator - Level 2
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
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6
IRE_Production Operator - Level 2
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Summary of Role:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
7
Maintenance Technician (Night Shift)
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are now looking for a **Maintenance Technician** (Permanent role) to join our team in Dundalk, County Louth.
This is a **Night Shift** role, covering Monday to Wednesday 12 hours shift (7pm to 7am).
**Profile:**
Hands on engineer with ability to maximize machine reliability and throughput while supporting new projects.
A self-starter with initiative to drive the team forward in a co-operative yet assertive manner.
Ability to synthesise information from various sources and analyse and decide on a course of action.
**Primary Responsibilities:**
+ Maximise the efficiency of engineering personnel and equipment.
+ Directly responsible for acting on machines to ensure that yield and cycle time targets are met.
+ Execute job cards and ensure sufficient close out of the jobs.
+ Ensure preventive maintenance system is maintained and work complete in time.
+ Liaise with Production supervisor on resolution of technical issues.
+ Responsible for Installation and Setup of Tooling and Camera Systems. Monitoring and ensuring daily adherence to Standard Operating Conditions / Validated Parameters on all equipment In Production.
+ Assist Quality / Engineering / Project Introduction with 'new material / systems / projects or trials in production when required. - scoping, defining and implementation of mechanical and electrical modifications.
+ Assist in development and training of other Technicians, Machine setters and Operators in their roles.
+ Management of booking out spares.
+ Ensure safe work practices are being always followed- support H&S representative.
+ Ensure close out of "see cards".
+ LOTO procedure is adhered to.
+ Ensure that all activities are following the requirements of Good Manufacturing Practice.
+ Ensure excellence in Housekeeping and the cleaning schedule is adhered to.
+ Ensure close out of CAPA's, Deviations and memos.
+ Work in conjunction with other departments, QA, Production, logistics etc. to improve performance of company.
+ Carry out various other additional tasks that may be required by the Engineering Manager.
**Essential:**
+ Craft / trade fault finding electrician or mechanical certificate.
**Desirable:**
+ GMP / Pharma / Packaging experience.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
We are now looking for a **Maintenance Technician** (Permanent role) to join our team in Dundalk, County Louth.
This is a **Night Shift** role, covering Monday to Wednesday 12 hours shift (7pm to 7am).
**Profile:**
Hands on engineer with ability to maximize machine reliability and throughput while supporting new projects.
A self-starter with initiative to drive the team forward in a co-operative yet assertive manner.
Ability to synthesise information from various sources and analyse and decide on a course of action.
**Primary Responsibilities:**
+ Maximise the efficiency of engineering personnel and equipment.
+ Directly responsible for acting on machines to ensure that yield and cycle time targets are met.
+ Execute job cards and ensure sufficient close out of the jobs.
+ Ensure preventive maintenance system is maintained and work complete in time.
+ Liaise with Production supervisor on resolution of technical issues.
+ Responsible for Installation and Setup of Tooling and Camera Systems. Monitoring and ensuring daily adherence to Standard Operating Conditions / Validated Parameters on all equipment In Production.
+ Assist Quality / Engineering / Project Introduction with 'new material / systems / projects or trials in production when required. - scoping, defining and implementation of mechanical and electrical modifications.
+ Assist in development and training of other Technicians, Machine setters and Operators in their roles.
+ Management of booking out spares.
+ Ensure safe work practices are being always followed- support H&S representative.
+ Ensure close out of "see cards".
+ LOTO procedure is adhered to.
+ Ensure that all activities are following the requirements of Good Manufacturing Practice.
+ Ensure excellence in Housekeeping and the cleaning schedule is adhered to.
+ Ensure close out of CAPA's, Deviations and memos.
+ Work in conjunction with other departments, QA, Production, logistics etc. to improve performance of company.
+ Carry out various other additional tasks that may be required by the Engineering Manager.
**Essential:**
+ Craft / trade fault finding electrician or mechanical certificate.
**Desirable:**
+ GMP / Pharma / Packaging experience.
#LI-VR1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
8
Operations Manager
Dundalk, Leinster
PCI Pharma Services
Posted 14 days ago
Job Viewed
Job Description
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Purpose of the Role**
The Operations Manager is responsible for the day-to-day management of warehouse and production operations, ensuring seamless coordination, compliance, and performance across both functions. This role will lead, support, and develop the Warehouse and Production Supervisors to meet operational targets, ensure inspection readiness, and drive a culture of continuous improvement, safety, and collaboration.
The Operations Manager will act as a key link between the Operations Director and front-line supervisors to translate business objectives into clear operational deliverables.
**Key Responsibilities**
+ Provide leadership, direction, and coaching to Warehouse and Production Supervisors.
+ Monitor daily performance across warehouse and production functions to ensure alignment with planning, quality, and safety targets.
+ Drive accountability for achieving KPIs, including output, inventory accuracy, compliance, and delivery performance.
+ Lead daily tiered meetings to ensure communication, issue resolution, and operational alignment.
+ Ensure both production and warehouse activities meet GMP, GDP, Health & Safety, and regulatory standards.
+ Support audit readiness across functions; participate in inspections and own closure of cross-functional CAPAs where applicable.
+ Champion adherence to SOPs, batch documentation standards, and good documentation practices.
+ Collaborate with Planning, QA, and Supply Chain to ensure seamless flow of materials and timely completion of production plans.
+ Monitor and mitigate risks that may impact schedule adherence or material availability.
+ Identify and lead cross-functional improvement initiatives focused on productivity, cost-efficiency, safety, and quality.
+ Support root cause analysis, lead investigations when required, and ensure effective implementation of corrective actions.
+ Develop and maintain multiskilled and flexible teams through structured cross-training programs.
+ Conduct performance reviews, coaching, and development planning for direct reports.
+ Foster a positive, safety-first culture that encourages engagement and accountability.
+ Provide timely updates to the Operations Director on operational performance, risks, and improvement plans.
+ Ensure escalation procedures are followed effectively and that decision-making is data-driven and prompt.
**Qualifications**
+ Bachelor's Degree, Diploma, or Certificate in logistics, supply chain, or related field (or equivalent experience).
+ Evidence of Continuous Professional Development.
**Key Requirements**
+ Minimum 5 years of experience in operations leadership within a GMP-regulated manufacturing or logistics environment.
+ Strong knowledge of production and warehousing workflows, regulatory compliance, and EHS practices.
+ Proven ability to manage, develop, and lead cross-functional teams.
+ Demonstrated experience in continuous improvement, problem-solving, and performance management.
+ Excellent communication, planning, and organisational skills.
+ Proficiency in ERP systems (e.g., JDE) and lean manufacturing tools preferred
#LI-MS1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Purpose of the Role**
The Operations Manager is responsible for the day-to-day management of warehouse and production operations, ensuring seamless coordination, compliance, and performance across both functions. This role will lead, support, and develop the Warehouse and Production Supervisors to meet operational targets, ensure inspection readiness, and drive a culture of continuous improvement, safety, and collaboration.
The Operations Manager will act as a key link between the Operations Director and front-line supervisors to translate business objectives into clear operational deliverables.
**Key Responsibilities**
+ Provide leadership, direction, and coaching to Warehouse and Production Supervisors.
+ Monitor daily performance across warehouse and production functions to ensure alignment with planning, quality, and safety targets.
+ Drive accountability for achieving KPIs, including output, inventory accuracy, compliance, and delivery performance.
+ Lead daily tiered meetings to ensure communication, issue resolution, and operational alignment.
+ Ensure both production and warehouse activities meet GMP, GDP, Health & Safety, and regulatory standards.
+ Support audit readiness across functions; participate in inspections and own closure of cross-functional CAPAs where applicable.
+ Champion adherence to SOPs, batch documentation standards, and good documentation practices.
+ Collaborate with Planning, QA, and Supply Chain to ensure seamless flow of materials and timely completion of production plans.
+ Monitor and mitigate risks that may impact schedule adherence or material availability.
+ Identify and lead cross-functional improvement initiatives focused on productivity, cost-efficiency, safety, and quality.
+ Support root cause analysis, lead investigations when required, and ensure effective implementation of corrective actions.
+ Develop and maintain multiskilled and flexible teams through structured cross-training programs.
+ Conduct performance reviews, coaching, and development planning for direct reports.
+ Foster a positive, safety-first culture that encourages engagement and accountability.
+ Provide timely updates to the Operations Director on operational performance, risks, and improvement plans.
+ Ensure escalation procedures are followed effectively and that decision-making is data-driven and prompt.
**Qualifications**
+ Bachelor's Degree, Diploma, or Certificate in logistics, supply chain, or related field (or equivalent experience).
+ Evidence of Continuous Professional Development.
**Key Requirements**
+ Minimum 5 years of experience in operations leadership within a GMP-regulated manufacturing or logistics environment.
+ Strong knowledge of production and warehousing workflows, regulatory compliance, and EHS practices.
+ Proven ability to manage, develop, and lead cross-functional teams.
+ Demonstrated experience in continuous improvement, problem-solving, and performance management.
+ Excellent communication, planning, and organisational skills.
+ Proficiency in ERP systems (e.g., JDE) and lean manufacturing tools preferred
#LI-MS1
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled
This advertiser has chosen not to accept applicants from your region.
9