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**Job Function: **
Supply Chain Engineering
**Job Sub Function: **
Process Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Nijmegen, Netherlands
Job Description:
Position: Senior Process Engineer (initially 1-year Fixed Term)
Report to: Engineering Manager
Location: Nijmegen, Netherlands (Fully Onsite Role)
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Job Description
GATT-technologies, a Johnson & Johnson Company is recruiting for a **Senior Process Engineer **located in Nijmegen.
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 project to enhance safety, quality, yield and efficiency.
- Defining, monitoring, and reporting key performance indicators (KPIs) for process performance, equipment utilization, downtime, scrap, and yield; drive 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; author/review 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.
- 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 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 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 (e.g., 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.
This is what awaits YOU at J&J:
This is an opportunity to work within groundbreaking MedTech and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional disciplines and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the 1000+ people who work here, or you’re considering joining the team, we offer:
- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Opportunities to work on challenging projects and assignments.
- Possibilities for further personal and professional development/education
- Excellent Benefits
#LI-SP5
**Required Skills: **
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
The anticipated base pay range for this position is:
€53.500,00 - €85.445,00
Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.