Process / Project Engineer – nPVC 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 (nPVC) 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 nPVC bags, ports, connectors, and assemblies.
Support conversion from PVC to nPVC 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 nPVC 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.
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