125 Jobs in Drogheda

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.
**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

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

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

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

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**
A key member of the Quality Leadership Team that influences the wider organisation by demonstrating leadership through actions, accountability coaching and development of the Quality Operations, and function departments Quality work closely with. This role requires a self-starter who likes working with the freedom to manage their own area and take responsibility. This is a key succession planning opportunity within the QA organisation.
**Technical**
The role of the Quality Manager is to lead the QA Operations Team. Define/improve the process with Quality Operations. Responsibility for implementation and execution tasks relating to Batch File life cycle, Process, Facility, Cleaning/Housekeeping from a Quality perspective at PCI Ireland Pharma Services. Customer point of contact, working to ensure OTIF of batch records and Customer commitments.
**Main Responsibilities**
+ Manage the generation and review of all batch manufacturing records within the business unit as part of production start-up and post batch review activities, ensuring agreed timelines are met.
+ Direct quality activities within the incoming goods receipt area.
+ The Quality Manager is responsible for communicating the strategy to Quality leadership and working closely with all functional departments to ensure the Quality Operational requirements are understood and ultimately adhered to.
+ Ensuring all Quality Operations activities on site relating to Facility, Laboratory Equipment, CSV, Processes (packaging and cleaning), and Data Integrity meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA).
+ Define Quality Operations KPI's, and batch schedule. Utilise SQDC to manage operations for quality and provide weekly summary of SQDC outputs to Quality Director.
+ Review and approve deviations and investigations arising from the process or related to the products packed in the business unit and respond to customer queries related to product investigations.
+ Manage the Quality Operations team. Train, develop, coach the team on the incoming goods, bath file review, Events, Deviation, Non Conformance systems, documenting, and execution. Manage HR related activities. Complete Quantum for Team and yourself in a timely manner ensuring 1:1 conversation happen on time and team is aware for expectations.
+ The Quality Manager is a key member of the Quality Site Leadership team. In that capacity the incumbent must flag concerns with site Operations should any be found, work with other departments (Engineering, Production, NPI, QC and others) to ensure the Quality Operation needs are understood. Quality Operations department must utilise risk methodology, be pragmatic, solution orientated with overall focus on Quality compliance across the sites.
+ Host Customer inspections (audits), visits and support HA authority inspections as required.
+ Be a Leader, continue to drive good practice (cultural and technical) across the site, and continually improve the Quality system.
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

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 **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

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 **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

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

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