Senior Process Engineer, Nijmegen

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.

Key Responsibilities

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.

Qualifications&Experience

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.

Pay&Benefits 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.

Required/Preferred Skills

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.

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