We are seeking a skilled Senior Process Engineer to join a high-performing team at a leading medical device manufacturing facility. This role will focus primarily on equipment revalidations and machine relocations, involving both hands-on technical work and comprehensive documentation responsibilities. This role is ideal for someone with strong attention to detail, excellent planning skills, and a solid background in regulated manufacturing environments. The role is fully onsite.
Key Responsibilities:
- Lead and support revalidation efforts for production equipment
- Develop and execute relocation protocols for a range of machinery
- Create and maintain detailed IQ documentation using existing templates
- Participate in and support equipment moves within the facility
- Ensure compliance with internal validation procedures and regulatory standards
- Collaborate with cross-functional teams to complete documentation efficiently and accurately
- Leverage prior experience in authoring technical and validation documents
- Proactively resolve issues and ensure smooth execution of revalidation processes
Equipment Scope May Include:
- CNC machines
- Coating machines
- Packaging equipment
- Utility panels
- Other production and manufacturing assets
Ideal Candidate Profile:
- Degree-qualified in Engineering (Level 7 minimum; Level 8 preferred)
- Proven experience in equipment validation, revalidation, and technical documentation
- Strong background in authoring validation and commissioning documentation
- Solid understanding of GMP requirements in medical device or similarly regulated industries
- Detail-oriented, organized, and capable of independently driving documentation through to completion
- Strong communication skills and ability to work within a small, focused team
