Senior Process Engineer, Amsterdam

Senior Process Engineer (initially 1-year Fixed Term).

Location:

Nijmegen, Netherlands.

Reports to:

Engineering Manager.

Job Function:

Supply Chain Engineering– Process Engineering. This role provides technical leadership for manufacturing processes and equipment, driving safety, quality, yield and throughput improvements in a regulated medical device environment. Responsibilities

Identify improvement opportunities and lead projects to enhance safety, quality, yield and efficiency. Define, monitor and report key performance indicators (KPIs) for process performance, equipment utilization, downtime, scrap, and yield; drive actions based on performance and risk. Lead manufacturing equipment and process validation/qualification activities, including creation of validation strategies and plans.Define requirements (URS) and support supplier acceptance (FAT/SAT), and execute IQ/OQ/PQ; author and review protocols and reports in line with GMP and ISO13485 expectations. Lead and execute approved change controls. Lead problem‑solving and provide 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 or participate in nonconformance investigations and CAPAs related to manufacturing processes and equipment; ensure actions are effective, documented and closed on time.Support internal and external audits and maintain inspection readiness. Follow all company safety, health and environmental policies and regulatory requirements. Qualifications

Bachelor’s or Master’s degree in Engineering (Mechanical, Manufacturing, Biomedical, Chemical) or a related technical discipline. Minimum 5 years process engineering experience in manufacturing, including hands‑on troubleshooting and implementation in a production environment. Experience in a regulated manufacturing environment (ClassIII sterile medical devices preferred); working knowledge of ISO13485 and ISO14971, and familiarity with FDA QSR/QMSR is a plus.Demonstrated experience with change control, deviation/nonconformance investigations, CAPA, and engineering documentation (protocols, reports, work instructions) 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, communication, stakeholder management and technical leadership skills with the ability to influence without authority. Demonstrated ability to work in accordance with procedures, maintain high documentation quality, and manage multiple priorities in a fast‑paced, regulated environment.Required 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 AwarenessSupply Planning Technical Research Technologically Savvy Validation Testing Benefits and Compensation

Anticipated base pay range:€53,500.00 – €85,445.00. Benefits include an annual bonus with a set target (percentage of pay), vacation days, parental leave (minimum 12 weeks), bereavement leave, caregiver leave, voluntary leave, well‑being reimbursement, programs for financial, physical and mental health, service‑anniversary and recognition awards, and various insurance plans, subject to local terms.

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