Job Information
PCI Pharma Services Process Engineer, Serialization in Stamullen Co. Meath, Ireland
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.
Main purpose of job:
Working within the Engineering function for PCI Pharma Services (Ireland Sites) the Serialization Process Engineer will act as the Serialization Subject Matter Expert (SME) with a deep understanding of serialization requirements and implementation within pharmaceutical supply chain operations. The serialization process engineer will have extensive experience in defining, deploying, and maintaining serialization solutions, while ensuring compliance with global regulations and industry standards.
The serialisation Process Engineer will have a proven track record in troubleshooting serialization equipment issues and be capable of understanding and optimising machine performance, be strong in a team environment and possess excellent coordination skills.
Main responsibilities:
Responsible for process engineering within PCI’s Ireland operations including:
Serve as the primary point of contact and subject matter expert for pharmaceutical serialization and track-and-trace technologies, providing guidance on regulatory requirements, industry best practices, and technical implementation strategies.
Collaborate with cross-functional teams, including regulatory, quality assurance, supply chain, IT, PCI global serialization team and external partners, to define serialization strategies, requirements, and roadmaps that align with global regulations and business objectives.
Lead the evaluation, selection, and implementation of serialization technologies, including serialization software, hardware, labeling systems, and data management solutions.
Develop and maintain serialization-related documentation, including technical specifications, standard operating procedures (SOPs), and data governance policies, to support regulatory compliance and operational excellence.
Provide expertise in troubleshooting serialization issues, managing exceptions, and investigating discrepancies related to serialized product data, ensuring timely resolution and compliance with regulatory reporting requirements.
Stay informed about emerging trends, regulations, and standards in pharmaceutical serialization and track-and-trace, proactively assessing the impact on current and future serialization strategies and proposing recommendations for adaptation.
Contribute to the training and development of internal teams and external partners on serialization principles, system operation, and compliance requirements, fostering a culture of awareness and adherence to serialization best practices.
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 primary, secondary and territory 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.
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, 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 Behaviours.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
Scope and Authority:
The job holder is responsible for adhering to the company’s SOPs, Health & Safety, cGMP and other regulatory guidelines themselves and for team members and contractors under their control.
The job holder is responsible for managing and maintaining capital project budgets as and where appropriate.
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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
Equal 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.
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