136 Jobs in Drogheda
Quality Operations Manager FT

Posted 5 days ago
Job Viewed
Job Description
**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
Accounts Receivable Administrator
Posted 14 days ago
Job Viewed
Job Description
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.
IRE_Production Operator - Level 2

Posted 17 days ago
Job Viewed
Job Description
**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
Process Engineer, Packaging Processes

Posted 17 days ago
Job Viewed
Job Description
**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 **Process Engineer, Packaging Processes** (permanent role) to join our team. This is a Monday to Friday position, 100% on-site.
**Main purpose of job**
Working within the Engineering function for PCI Pharma Services (Ireland Sites) the **Process Engineer, Packaging Processes** will act as the Subject Matter Expert (SME) for assigned packaging processes within the technical function of Engineering. The Packaging Process Engineer will display strong technical ability and have interpersonal and communication skills that build the strongest of relationships at department and site level.
The **Process Engineer, Packaging Processes** will have a proven track record in troubleshooting equipment issues and be capable of understanding and optimising machine performance, be strong in a team environment and possess excellent coordination skills.
**Key Responsibilities**
Responsible for process engineering within PCI's Ireland operations including:
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Responsible for process engineering within PCI's Ireland operations including:
+ Take responsibility for assigned packaging process(es) and become the site SME educating and training others. Work with vendors to better understand the technology and seek to optimize it's capability to benefit site and customer projects.
+ Analyze process data for assist and or lead Continuous Improvement (CI) Projects and operational issues as required, including all OEE (Overall Equipment Effectiveness) projects to ensure improved efficiencies, reduced waste and cost.
+ Population and maintenance of the Technical Drawing & equipment specification data base, this is to include the generation, recording, filing and archiving of withdrawn / superseded Technical Drawings and associated documentation.
+ Focus on delivery - Right First Time (RFT) and On Time in Full (OTIF).
+ Support the development of PCI internal engineering processes/workflows with an aim to reduce wastage and improve efficiencies across various workstreams and initiatives.
+ Build, develop and sustain the knowledge, capability and competency within the Engineering team to support ongoing and changing technologies employed to meet the business objectives.
+ Ensure compliance with all labelling, secondary and tertiary packaging tooling ways of working and specifications for the ordering, receipt inspection, storage and control.
+ Support the execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for assigned area of expertise.
+ Support the execution of Qualification and Validation activities involving implementation of new equipment and/or new components.
+ Support troubleshooting of packaging process deviations and events, conducting root cause analyses to address quality and performance issues, and leading implementation of corrective and preventive actions (CAPAs and Action Items) applied to the process.
+ Ensure technical engineering documentation is completed in a timely manner as per site procedures supporting Good Engineering Practice (GEP).
+ Work in conjunction with Procurement to identify preferred suppliers for engineering services and materials.
+ Support the risk management process through involvement in risk assessment for new (or modified) equipment and new processes.
+ In conjunction with Operations lead or support technical, perform product and process reviews to resolve operational, performance and functional issues.
+ Monitoring of future technologies and market trends identifying areas for potential investment in new technologies including reporting and recommendations to the Engineering management team.
+ Identification of future CapEx projects to improve the business offerings and competitive edge.
+ Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and technical standards, procedures and systems.
+ Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviors.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Educated to EQF (European Qualifications Framework) level 6 in a Technical, Engineering or a Science subject OR significant experience in industry.
+ Min 2 years' experience of engineering within a pharmaceutical facility relating to labelling and packaging process.
+ Knowledge of pharmaceutical packaging equipment, packaging materials, technologies and challenges with each.
+ Detailed understanding of facility and engineering issues and processes.
+ Experience in a GMP or Regulated Environment.
+ Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Effective communication - internal and external.
+ Team working - display obvious signs of ability to work in high performing complex teams.
+ Mentoring and coaching - Able to act as a coach and mentor to others.
+ Analytical and data-driven
+ Attention to detail and persistence.
+ Customer centric.
+ Committed to the highest levels of integrity, ethics and professionalism
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
+ Master's degree in a Technical, Engineering or a Science subject.
#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
Process Engineer, Packaging Processes

Posted 17 days ago
Job Viewed
Job Description
**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 **Process Engineer, Packaging Processes** (permanent role) to join our team. This is a Monday to Friday position, 100% on-site.
**Main purpose of job**
Working within the Engineering function for PCI Pharma Services (Ireland Sites) the **Process Engineer, Packaging Processes** will act as the Subject Matter Expert (SME) for assigned packaging processes within the technical function of Engineering. The Packaging Process Engineer will display strong technical ability and have interpersonal and communication skills that build the strongest of relationships at department and site level.
The **Process Engineer, Packaging Processes** will have a proven track record in troubleshooting equipment issues and be capable of understanding and optimising machine performance, be strong in a team environment and possess excellent coordination skills.
**Key Responsibilities**
Responsible for process engineering within PCI's Ireland operations including:
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Responsible for process engineering within PCI's Ireland operations including:
+ Take responsibility for assigned packaging process(es) and become the site SME educating and training others. Work with vendors to better understand the technology and seek to optimize it's capability to benefit site and customer projects.
+ Analyze process data for assist and or lead Continuous Improvement (CI) Projects and operational issues as required, including all OEE (Overall Equipment Effectiveness) projects to ensure improved efficiencies, reduced waste and cost.
+ Population and maintenance of the Technical Drawing & equipment specification data base, this is to include the generation, recording, filing and archiving of withdrawn / superseded Technical Drawings and associated documentation.
+ Focus on delivery - Right First Time (RFT) and On Time in Full (OTIF).
+ Support the development of PCI internal engineering processes/workflows with an aim to reduce wastage and improve efficiencies across various workstreams and initiatives.
+ Build, develop and sustain the knowledge, capability and competency within the Engineering team to support ongoing and changing technologies employed to meet the business objectives.
+ Ensure compliance with all labelling, secondary and tertiary packaging tooling ways of working and specifications for the ordering, receipt inspection, storage and control.
+ Support the execution of Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for assigned area of expertise.
+ Support the execution of Qualification and Validation activities involving implementation of new equipment and/or new components.
+ Support troubleshooting of packaging process deviations and events, conducting root cause analyses to address quality and performance issues, and leading implementation of corrective and preventive actions (CAPAs and Action Items) applied to the process.
+ Ensure technical engineering documentation is completed in a timely manner as per site procedures supporting Good Engineering Practice (GEP).
+ Work in conjunction with Procurement to identify preferred suppliers for engineering services and materials.
+ Support the risk management process through involvement in risk assessment for new (or modified) equipment and new processes.
+ In conjunction with Operations lead or support technical, perform product and process reviews to resolve operational, performance and functional issues.
+ Monitoring of future technologies and market trends identifying areas for potential investment in new technologies including reporting and recommendations to the Engineering management team.
+ Identification of future CapEx projects to improve the business offerings and competitive edge.
+ Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and technical standards, procedures and systems.
+ Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviors.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
**Knowledge / Skills & Experience**
**Essential:**
+ Educated to EQF (European Qualifications Framework) level 6 in a Technical, Engineering or a Science subject OR significant experience in industry.
+ Min 2 years' experience of engineering within a pharmaceutical facility relating to labelling and packaging process.
+ Knowledge of pharmaceutical packaging equipment, packaging materials, technologies and challenges with each.
+ Detailed understanding of facility and engineering issues and processes.
+ Experience in a GMP or Regulated Environment.
+ Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Effective communication - internal and external.
+ Team working - display obvious signs of ability to work in high performing complex teams.
+ Mentoring and coaching - Able to act as a coach and mentor to others.
+ Analytical and data-driven
+ Attention to detail and persistence.
+ Customer centric.
+ Committed to the highest levels of integrity, ethics and professionalism
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
+ Master's degree in a Technical, Engineering or a Science subject.
#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
Facilities Manager

Posted 17 days ago
Job Viewed
Job Description
**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 have a very exciting opportunity for a **Facilities Manager** (Permanent role) to join us on our journey of expansion, enabling us to build a strong culture and brand for PCI in Ireland. This role will be primarily based in Dundalk and is ideal for someone looking for their next challenge, see below for further details of the role. ?This is a Monday to Friday position, 100% on-site.
**Key Responsibilities:**
To have oversight and control through assigned resources to manage and deliver the following tasks in a Pharma GMP environment.
+ Employ sound technical expertise to ensure that facility and plant equipment is
+ maintained, supported and available.
+ Work in close collaboration with other related functions to deliver required outputs on a 24/7 shift basis.
+ Demonstrate excellent communication and assertiveness skills with strong attention to detail.
+ Manage Contracts: Utilities / Security / Cleaning / Pest Control /Landscaping/ Fire Protection / Security Alarms / CCTV / Access control / Waste Management / Calibrations and other related facilities systems.
+ Lead, supervise, performance-manage and develop a facilities support team of engineers and technicians, whom are operating on a 24/5 and weekend basis.
+ Updating relevant SOP's, documentation and technical papers.
+ Work closely with Site stakeholders to successfully deliver outputs and capacity enhancement projects.
+ Provide technical support for new projects, retrofits, product introduction and product transfers.
+ Address and effectively manage documentation issues arising from engineering activities.
+ Drive Continuous Improvement initiatives (e.g TPM, Lean, 6 Sigma, .).
+ Assist and in cases lead technical improvements under the department's continuous improvement program.
+ Work in close collaboration with equipment vendors to address any performance issues.
+ Manage and lead a team of engineers, technicians and tool room operatives with focus on following key areas. Scheduling / Supervision of workload and holidays /overtime for facilities staff, Defining, controlling and documenting engineering practices, Development and implementation of maintenance programs associated with the introduction of new and existing facility equipment, services and infrastructure. Schedule design & oversee Preventative Maintenance Work Procedures and maintenance of records.
+ Problem solving and troubleshooting equipment issues during start-up, continuous operation and qualification.
+ Works in a collaborative manner within the QA team structure and contributes to investigations, Cross Functional Investigations etc.
+ Budget management and forecasting for assigned area. Inc. Purchasing and management of spares, capital materials and consumables.
+ Assist with Installation and Operational Qualification of new and existing equipment.
+ Lead and Attend Daily Handover meetings to review issues or by designation.
+ To organise and supervise outside contractors i.e. calibration/service contracts.
+ To organise, manage and integrate new employees into the group.
+ To maintain high standards of cleanliness, hygiene and GMP at all times.
+ Responsible for safe working practices within their area. To adhere to all company and legislative health, safety and environmental requirements.
+ To undertake additional tasks as assigned by the Engineering Director or those designated by the Engineering Director.
**Experience Required:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
+ Degree in Engineering (mechanical/electrical) is essential.
+ At least 4- 10 years' experience in a similar role in a GMP-regulated / FMEA manufacturing inc. audit experience desirable.
+ Exposure to facilities equipment best-practice maintenance including CMMS and RCM. History in Continuous Improvement and lean production / engineering techniques.
+ Excellent written/verbal communicator and good documentation skills.
+ Good collaborator with ability to work on own initiative with minimal direction.
+ Numerate with good financial/budgeting skills.
+ Basic working knowledge of Microsoft Office family of products / AutoCAD is an advantage.
#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
IRE_Production Operator - Level 2

Posted 17 days ago
Job Viewed
Job Description
**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.
**ummary 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.**
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
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IRE_Production Operator - Level 2

Posted 17 days ago
Job Viewed
Job Description
**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
Production Operator - Level 2

Posted 17 days ago
Job Viewed
Job Description
**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
IRE_Production Operator - Level 2

Posted 17 days ago
Job Viewed
Job Description
**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