Process / Project Engineer n PVC Systems & Advanced Manufacturing Location: Castlebar, Ireland Contract: 12-month contract (potential extension) Role Overview Opportunity for an experienced engineer to support the industrialisation and scale-up of non-PVC (n PVC) medical device systems.
This role focuses on polymer-based manufacturing, container-closure systems, capital equipment, and validation within a regulated environment.
Key Responsibilities Technical & Process Development Lead design transfer and industrialisation of n PVC bags, ports, connectors, and assemblies.
Support conversion from PVC to n PVC materials and multilayer film technologies.
Provide expertise in sealing, forming, and container-closure integrity.
Capital Equipment & Automation Define URS for new/modified equipment (bag porting, connector welding, automated assembly).
Support vendor engagement, FAT/SAT, installation, and commissioning.
Ensure equipment scalability and alignment with automation needs.
Validation & Compliance Lead IQ/OQ/PQ for new and modified processes.
Support sterilisation validation and equivalency strategies.
Prepare and approve GMP-compliant documentation (protocols, reports, risk assessments).
Regulatory Support Contribute to regulatory-critical changes (supplier qualification, material changes, E&L, biocompatibility).
Ensure technical justifications are audit-ready.
Cross-Functional Collaboration Work with Manufacturing, Quality, R&D, Procurement, Regulatory, and suppliers.
Support alignment across global sites and lead structured problem-solving.
Requirements Essential Level 8+ degree in Mechanical, Polymer, Biomedical, Manufacturing Engineering, or similar.
5+ years in Medical Device, Pharma, or regulated manufacturing.
Strong polymer manufacturing experience (films, extrusion, moulding, packaging).
Proven capital project delivery and process validation (IQ/OQ/PQ).
Knowledge of SPC, DOE, OEE, and process optimisation.
Desirable Experience with n PVC systems, multilayer films, or polyolefin elastomers.
Experience with sterile bag-based products or dialysis systems.
Knowledge of sealing technologies, container-closure integrity, and sterile packaging.
Exposure to E&L, biocompatibility, and regulatory-impacting changes.
Skills & Attributes Strong technical judgement and hands-on problem-solving.
Effective communicator with cross-functional teams.
Self-driven, organised, and comfortable in fast-moving environments.
Excellent documentation discipline.