Senior Process Engineer - Orthopaedics

Johnson & Johnson Johnson & Johnson · Pharma · Leeds, West Yorkshire, United Kingdom

Senior Process Engineer for Orthopaedics at Johnson & Johnson, focusing on optimizing manufacturing value streams for medical devices. Responsibilities include process development, validation (IQ, OQ, PQ), quality action closure, technical collaboration, problem-solving, cost reduction initiatives, and mentorship. Requires a Bachelor's degree in Engineering and demonstrated experience in manufacturing/process engineering, validation, quality systems, and problem-solving.

What you'd actually do

  1. Provide hands‑on engineering leadership to achieve key business metrics (HSE, Quality, Supply, Cost) across assigned value streams.
  2. Lead end‑to‑end process development and industrialization for complex processes and New Product Introductions (NPI), ensuring scalable, robust, and validated manufacturing processes.
  3. Develop, plan, and implement complex validation strategies and protocols including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ); review and approve validation work and ensure regulatory compliance.
  4. Own and drive closure of high‑impact quality actions (Audit Actions, NCRs, CAPAs), prioritize resources, and ensure sustained corrective and preventive measures.
  5. Serve as the primary technical collaborator with R&D, Quality, Supply Chain, Maintenance, and external suppliers to specify tooling, fixtures, gauges and special equipment.

Skills

Required

  • Bachelor's degree or equivalent experience in Engineering
  • Demonstrated ability in manufacturing/process engineering
  • Demonstrated experience leading validation activities including IQ, OQ and PQ for equipment, processes and systems
  • Proven track record managing Audit Actions, NCRs and CAPAs within a Quality Management System
  • Strong experience in structured problem solving and root cause analysis
  • Excellent technical content skills (specifications, validation protocols, change control)
  • Experience leading multi-functional teams and influencing collaborators at multiple levels
  • Proven experience supporting NPI

What the JD emphasized

  • validation
  • Quality Management System
  • NPI