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Process Engineer, Serialization, Stamullen
Client: PCI Pharma Services
Location: Stamullen, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: d10cd7a69739
Job Views: 6
Posted: 03.06.2025
Expiry Date: 18.07.2025
Job Description:
Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
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, ensuring compliance with global regulations and industry standards.
The serialization Process Engineer will have a proven track record in troubleshooting serialization equipment issues, understanding and optimizing machine performance, and possess excellent coordination skills in a team environment.
Main responsibilities:
* Serve as the primary point of contact and SME for pharmaceutical serialization and track-and-trace technologies, providing guidance on regulatory requirements, industry best practices, and technical strategies.
* Collaborate with cross-functional teams to define serialization strategies, requirements, and roadmaps aligned with regulations and business goals.
* Lead the evaluation, selection, and implementation of serialization technologies, including software, hardware, labeling, and data management solutions.
* Develop and maintain serialization documentation, SOPs, and data governance policies for compliance and operational excellence.
* Troubleshoot serialization issues, manage exceptions, and investigate discrepancies to ensure compliance and timely resolution.
* Stay informed on emerging trends and regulations in serialization, assessing their impact and recommending adaptations.
* Contribute to training teams and external partners on serialization principles and compliance.
* Support continuous improvement projects, including OEE initiatives to enhance efficiency and reduce waste.
* Maintain technical drawings and equipment specifications, including documentation of technical drawings and updates.
* Focus on delivery metrics: Right First Time (RFT) and On Time in Full (OTIF).
* Support development of internal engineering processes to reduce waste and improve efficiency.
* Build and develop team knowledge and capabilities to support evolving technologies.
* Ensure compliance with packaging tooling standards and specifications.
* Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
* Complete technical documentation in line with site procedures and Good Engineering Practice (GEP).
* Work with Procurement to identify preferred suppliers for engineering services and materials.
* Participate in risk assessments for new or modified equipment and processes.
* Assist in resolving operational, performance, and functional issues through technical reviews.
* Monitor future technologies and market trends, reporting on potential investments and improvements.
* Identify future CapEx projects to enhance business offerings and competitiveness.
* Ensure all activities comply with statutory, regulatory, EHS, cGMP, and company standards.
* Create a positive working environment aligned with PCI values and behaviors.
* Manage specific or ad hoc projects as required to meet business needs.
Scope and Authority:
* Responsible for adhering to SOPs, safety, cGMP, and regulatory guidelines for themselves and team members.
* Manage and maintain capital project budgets where applicable.
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Join us and be part of building the bridge between life-changing therapies and patients.
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