Manufacturing Engineer, Groningen, Groningen

About the Company
An international medical device manufacturing organization is seeking an experienced Manufacturing Engineer to support equipment implementation and validation activities within a highly regulated production environment. In this role, you will work closely with engineering, quality, operations, and R&D teams to introduce new manufacturing technologies and equipment while ensuring compliance with quality and regulatory requirements. The position offers the opportunity to contribute to global manufacturing scalability and continuous improvement initiatives.

Role Description
As Manufacturing Engineer, you will be responsible for leading equipment validation and implementation activities across manufacturing operations. Acting as a validation subject matter expert, you will develop and execute validation strategies, create technical documentation, and ensure new equipment and processes meet business, quality, and regulatory requirements. You will play a key role in supporting the full lifecycle of equipment implementation, from requirements gathering and qualification through validation, deployment, and handover to operations.

Key Responsibilities

• Lead equipment implementation and validation activities within manufacturing operations
• Develop and execute validation strategies for new equipment and manufacturing processes
• Write and execute validation documentation including URS, TM, FAT, IQ, OQ, PQ, Validation Plans and Validation Summary Reports
• Gather requirements, user stories, and technical specifications for manufacturing equipment and software systems
• Act as Subject Matter Expert (SME) for GMP, GxP, and Computer System Validation (CSV) requirements
• Lead change control activities from initiation through closure, including protocol development, execution, reporting, and approval
• Collaborate with Engineering, Quality Assurance, Operations, R&D, and external suppliers throughout project execution
• Support equipment scalability and standardization across global manufacturing sites
• Design, develop, and implement test plans and validation protocols
• Perform equipment qualification and process validation activities
• Support documentation, training, and knowledge transfer to operational teams
• Ensure compliance with regulatory and quality requirements throughout implementation projects

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related technical discipline
• Minimum 5 years of experience in Manufacturing Engineering and/or Industrial Engineering within medium to high-volume manufacturing environments
• Proven experience as a Validation SME within Medical Devices, Pharmaceuticals, or another highly regulated cGMP environment
• Strong knowledge and practical experience with GMP, GxP, and CSV principles
• Experience leading validation projects and equipment qualification activities
• Experience with change control processes and validation lifecycle management
• Strong technical writing skills with experience creating validation and qualification documentation
• Excellent communication and stakeholder management skills
• Hands-on mentality with strong cross-functional collaboration capabilities

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