Staff 3d Process Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Raynham, MA +1

This role is for a Staff Process Engineer supporting manufacturing operations within the Additive Manufacturing (AM) value stream. The engineer will be responsible for process stability, continuous improvement, leading CAPA investigations, driving CIP initiatives, and collaborating with cross-functional teams. Key responsibilities include process development, industrialization, validation, quality action closure, problem-solving, and cost reduction initiatives.

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. Define equipment and process requirements, lead solving of recurring issues, and partner with maintenance and calibration to improve equipment reliability and uptime.

Skills

Required

  • Process development
  • Industrialization
  • Validation (IQ, OQ, PQ)
  • CAPA
  • Problem-solving
  • Risk assessment (FMEA, A3, Six Sigma)
  • Cost reduction initiatives
  • Manufacturing specifications
  • Quality Management System
  • Regulatory requirements

Nice to have

  • Additive Manufacturing (AM)
  • Orthopaedics
  • New Product Introductions (NPI)
  • Lean Manufacturing
  • Six Sigma