Senior Process Engineer, Nijmegen

Job Description Position: Senior 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 Senior Process Engineer provides technical leadership for manufacturing processes and equipment. This role leads cross‑functional initiatives to improve safety, quality, yield, throughput, and capacity; drives robust change control and process validation/qualification; and leads structured problem‑solving to reduce deviations and prevent recurrence through effective CAPA.

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; driving actions based on performance and risk.

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/reviewing protocols and reports in line with GMP and ISO 13485 expectations.

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.

Identifying and driving 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; ensuring actions are effective, documented, and closed on time.

Supporting internal/external audits and maintaining inspection readiness.

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

Following J&J Records Management Policies for convenience information, records retention schedules, training.

Following GMP requirements and working with the team to ensure all aspects of the business remain compliant and audit‑ready.

Communicating business‑related issues or opportunities to the next management level.

Ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.

Performing other duties assigned as needed.

Qualifications / Experience

Bachelor’s or Master’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 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 (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) to support robust process control.

Fluency in English; Dutch is preferred.

Strong 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.

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

Required Skills

Analytical reasoning.

Computerized equipment skills.

Preferred 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.

Salary Range€53,500.00 – €85,445.00 per annum.

Benefits

Annual bonus with set target (% of pay) depending on pay grade / location.

Sales commissions.

Vacation days.

Parental leave for a minimum of 12 weeks.

Bereavement leave.

Caregiver leave.

Volunteer leave.

Well‑being reimbursement.

Programs for financial, physical and mental health.

Service anniversary and recognition awards.

Various insurance plans (subject to terms of respective plans). Eligible dependents may participate depending on location policies.

#J-18808-Ljbffr