Job Family Group: Supply Chain Engineering
Job SummaryReporting to the Engineering LCM Manager, the Senior Process Engineer will lead and support projects that drive process improvements and increased capacity for Ethicon Biosurgery (GATT). This role identifies process‑related issues, implements corrective and preventive actions, and executes change controls to minimize manufacturing disruptions while ensuring compliance with GMP and company policies.
Key Responsibilities- Lead identification and implementation of process and equipment improvement opportunities to optimize throughput, yield, equipment utilization, and downtime.
- Own and execute change controls (e.g., prepare Change Requests/forms) and manage associated documentation and approvals.
- Provide hands‑on technical support to production for process deficiencies, process changes, equipment failures, and troubleshooting.
- Define, analyze, and resolve manufacturing issues promptly, including root‑cause analysis and effectiveness checks.
- Support investigation and resolution of non‑conformances and CAPAs related to manufacturing processes.
- Participate in GMP audits focusing on equipment recording and machine performance; support equipment/process validation (URS, FAT, SAT).
- Review and interpret vendor maintenance, calibration, and qualification reports; incorporate outcomes into manufacturing processes.
- Act as operations representative on multidisciplinary and global projects, communicating business issues and opportunities up the management chain.
- Provide guidance on environmental control and ensure EHS issues are reported via the EHS Management System.
- Ensure compliance with all federal, state, local, and Company regulations, policies, and procedures related to health, safety, and environment.
- Supervise or guide staff where applicable and ensure subordinates comply with HSE practices and have necessary resources.
- Perform other duties as assigned.
- Bachelor’s degree in Engineering required; Electrical, Mechanical, or Chemical preferred.
- 4–6+ years’ experience in process improvement or maintenance engineering, preferably within the medical device industry.
- Proven experience with GMP‑regulated manufacturing environments.
- Strong written and verbal communication in English; ability to present complex technical issues clearly.
- Demonstrated knowledge of manufacturing principles, equipment/process validation, and quality systems.
- Project management experience and ability to manage budgets, standard cost, and capital investments.
- Strong troubleshooting and machine design review skills.
- Ability to interpret vendor documentation and verify effectiveness of vendor work.
- Collaborative mindset with proven ability to build credibility across levels and functions.
- Customer‑centric focus, accountability for results, and ability to lead change.
- Capacity to simplify complex topics and engage stakeholders constructively.
- Relevant certifications (e.g., Six Sigma, PMP) are a plus but not required.
The anticipated base pay range for this position is 53,500 EUR to 85,445 EUR on an annual basis and includes 8% holiday allowance.
Location: Nijmegen, Netherlands.
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€53500 - €85445 monthly