Senior Process Engineer

Senior Process Engineer

Position:
Senior Process Engineer (initially 1-year Fixed Term) at Johnson & Johnson in Nijmegen, Netherlands.

Under the direction of the Engineering Manager, the Senior Process Engineer provides technical leadership for manufacturing processes and equipment.

• Identifying improvement opportunities and leading projects to enhance safety, quality, yield, and efficiency.
• Defining, monitoring, and reporting key performance indicators (KPIs) for process performance, equipment utilization, downtime, scrap, and yield.
• Leading manufacturing equipment and process validation/qualification activities, including creating validation strategies and plans, defining requirements (URS), and supporting supplier acceptance (FAT/SAT) and execution of IQ/OQ/PQ, authoring and reviewing protocols and reports in line with GMP and ISO 13485.
• Leading and executing approved change controls.
• Leading problem solving and providing hands‑on technical support to operations by troubleshooting process deviations, equipment failures, and yield losses using structured root‑cause analysis and defining robust corrective actions.
• Identify and drive continuous improvement initiatives (Lean/Six Sigma) to improve process reliability, capability, and robustness.
• Lead / participate in nonconformance investigations and CAPAs related to manufacturing processes and equipment; ensure effective documentation and closure.
• Support internal and external audits and maintain inspection readiness.
• Follow all company safety policies and GMP requirements.
• Communicate business‑related issues or opportunities to the next level of management.
• Perform other duties as assigned.

• Bachelor’s or Master’s degree in Engineering (Mechanical, Manufacturing, Biomedical, Chemical) or a related technical discipline.
• Experience in a regulated manufacturing environment (Class III sterile medical devices preferred); working knowledge of ISO 13485, ISO 14971, and familiarity with FDA QSR/QMSR.
• Minimum 5 years of process engineering experience in manufacturing, including hands‑on troubleshooting and implementation in a production environment.
• Demonstrated experience with change control, deviation/nonconformance investigations, CAPA, and engineering documentation in an ISO/GMP environment.
• Knowledge of equipment specification and qualification (URS, FAT/SAT, IQ/OQ/PQ) and ability to review machine designs, tooling/fixture concepts, and maintenance strategies.
• Working knowledge of risk management and statistical/quality tools (PFMEA, control plans, DOE, SPC, capability analysis, MSA/Gage R&R).
• Fluency in English;
  Dutch is preferred.
• Strong cross‑functional collaboration skills and ability to influence without authority.
• Strong communication, stakeholder management, and technical leadership skills.

Anticipated base pay range: €53,500 - €85,445.

Benefits include an annual bonus, vacation days, parental and bereavement leave, well‑being reimbursement, health insurance, and other company programs.

• Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements.
• Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing.