Process Engineer, Nijmegen

Job Function Supply Chain Engineering

Job Sub Function Process Engineering

Job Category Scientific/Technology

Job Posting Location Nijmegen, Netherlands

Job Description Position: Process Engineer (initially 1-year Fixed Term)

Report to: Engineering Manager

Location: Nijmegen, Netherlands (Fully Onsite Role)

Summary Of Role Under the direction of the Engineering Manager, the Process Engineer provides technical leadership for manufacturing processes and equipment. This role supports cross‑functional initiatives to improve safety, quality, yield, throughput, and capacity; drives robust change control and process validation/qualification; and supports structured problem solving to reduce deviations and prevent recurrence through effective CAPA.

Key Responsibilities

Identifying improvement opportunities and participating in projects to enhance safety, quality, yield and efficiency.

Monitoring, and reporting key performance indicators (KPIs) for process performance, equipment utilization, downtime, scrap, and yield; drive actions based on performance and risk.

Supporting 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; author/review protocols and reports in line with GMP and ISO 13485 expectations.

Supporting and executing change controls.

Participating in 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 supporting robust corrective actions.

Support continuous improvement initiatives (Lean/Six Sigma) to improve process reliability, capability, and robustness.

Participate in nonconformance investigations and CAPAs related to manufacturing processes and equipment; ensure actions are effective, documented, and closed on time.

Support internal/external audits and maintain inspection readiness.

Follow all company safety policies and other safety precautions within the work area.

Follow J&J Records Management Policies for Convenience Information, Records Retention Schedules, Training.

Follow GMP requirements.

Work with the team to ensure all aspects of the business remain compliant and, in an audit, ready state.

Responsible for communicating business‑related issues or opportunities to the next management level.

Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Performs other duties assigned as needed.

Qualifications / Experience

Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, Chemical) or related technical discipline.

Experience in a regulated manufacturing environment (Class III sterile medical devices preferred); working knowledge of ISO 13485 and ISO 14971; familiarity with FDA QSR/QMSR is a plus.

Minimum 3 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 (protocols, reports, work instructions) in an ISO/GMP environment.

Knowledge of equipment specification and qualification (URS, FAT/SAT, IQ/OQ/PQ).

Working knowledge of risk management and statistical/quality tools (e.g., PFMEA, control plans, DOE, SPC, capability analysis, MSA/Gage R&R) to support robust process control.

Fluency in English; Dutch is preferred.

Cross‑functional collaboration skills (Operations, Quality, Technical Operation, R&D, Supply Chain, suppliers) 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.

Good communication, stakeholder management, and technical leadership skills with the ability to build trust at all levels.

Required Skills

Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety‑Oriented, Science, Technology, Engineering, STEM Application, Situational Awareness, Technical Research, Technologically Savvy.

Preferred Skills

Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety‑Oriented, Science, Technology, Engineering, STEM Application, Situational Awareness, Technical Research, Technologically Savvy.

Benefits

Basic salary€44,700.00 - €70,840.00.

Annual bonus with set target (% of pay) depending on pay grade/location, based on employee and company performance.

Vacation days and parental leave for a minimum of 12 weeks.

Bereavement, caregiver, and volunteer leave.

Well‑being reimbursement and programs for financial, physical and mental health.

Service anniversary and recognition awards.

Health, dental, vision, and life insurance plans (subject to terms and location).

Eligibility for dependent benefits in some locations.

Other company perks and incentives as per local policies.

This is for informational purposes only. Amounts and benefits may vary by location and are subject to change.

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