Manufacturing/Process Engineer
Job Specification: Process Manufacturing Engineer (Medical Device)
Role Overview
We are seeking a Process Manufacturing Engineer with experience in the Medical Device or Pharmaceutical sector. The role will support manufacturing processes, with a strong focus on packaging systems, automation, equipment, and process validation. This position will play a key part in introducing a new product, ensuring all packaging elements, equipment, and processes meet regulatory, quality, and performance expectations.
Key Responsibilities
Packaging & Process Ownership
- Lead and manage packaging processes including trays, sealing, sterilisation, labelling, and printing systems.
- Oversee the development, optimisation, and validation of packaging workflows and equipment.
- Ensure compliance with medical device / pharma regulatory standards (ISO 13485, FDA, GMP, etc.).
Equipment & Systems
- Support selection, introduction, and qualification (IQ/OQ/PQ) of manufacturing and packaging equipment.
- Troubleshoot and improve performance of systems and automation equipment within manufacturing lines.
- Collaborate with equipment vendors and internal engineering teams as needed.
New Product Introduction (NPI)
- Support NPI activities, ensuring smooth transfer of new products into manufacturing.
- Lead process validation activities associated with new product packaging and manufacturing workflows.
- Contribute to risk assessments, process documentation, and design transfer deliverables.
Process Improvement & Validation
- Conduct process validations for packaging, automation, and manufacturing steps.
- Drive continuous improvement initiatives to enhance safety, efficiency, and product quality.
- Maintain complete and accurate technical documentation.
Experience & Skills Required
- Background in Medical Devices, MedTech, or Pharmaceuticals (highly preferred).
- Experience with packaging processes such as trays, sealing, sterilisation, labelling, and print systems.
- Hands‑on exposure to manufacturing equipment, automation, and system troubleshooting.
- Strong understanding of validation requirements: equipment qualification, process validation, and documentation.
- Experience supporting NPI, equipment transfers, and introduction of new systems or processes.
- Knowledge of relevant regulatory frameworks (GMP, ISO 13485, FDA/QSR, EU MDR).
FAQs
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