Our client is a leading manufacturer specializing in the packaging of cheese products for the global market. They serve major retail brands and supermarket chains worldwide, ensuring high-quality products are available on store shelves across the globe. The company emphasizes continuous improvement, safety, and operational excellence in their production processes.
About the RoleThe Manufacturing Engineer – Asset Management is responsible for leading equipment implementation and validation activities in a regulated manufacturing environment. You will collaborate closely with engineering, quality, operations, and suppliers to deliver compliant, scalable equipment solutions. Acting as a validation and GMP/GXP/CSV subject matter expert, you ensure design requirements, quality standards, and business targets are met. The role involves end-to-end ownership of validation documentation, testing, change control, and risk analysis. You will also support global rollout through robust documentation, SOPs, and training.
Responsibilities- Lead equipment validation activities by authoring and executing URS, FAT, IQ/OQ/PQ, CSV documentation and managing change controls through to closure in a GMP/GxP environment.
- Act as a validation and compliance SME, ensuring equipment and processes meet regulatory, quality, and business requirements within a medical device manufacturing setting.
- Collaborate cross‑functionally with R&D, QA, Operations, and external suppliers to implement and scale new or modified manufacturing equipment globally.
- Design and execute test plans and risk assessments, including root‑cause analysis, to validate equipment performance, process capability, and product quality.
- Support handover and operational readiness by developing SOPs, training materials, and technical documentation to ensure smooth transition to production teams.
- Bachelor’s degree in Mechanical, Electrical, Industrial, or a related Engineering discipline is required.
- Minimum 5 years of experience in Manufacturing, Industrial, or Equipment Engineering within a regulated (GMP/GxP, MedTech, Pharma) environment.
- Strong hands‑on experience with equipment validation activities including URS, FAT, IQ/OQ/PQ, CSV, and change control processes.
- Proven knowledge of GMP/GxP fundamentals, statistical analysis (e.g., Minitab), and Design for Manufacturing or Lean principles.
- Excellent communication skills in English, a collaborative mindset, and a proven track record as a validation SME in high‑volume manufacturing.
Looking for a new opportunity? If you're interested, please click the button below to apply.
#J-18808-Ljbffr€60000 - €75000 monthly