We are seeking a skilled Senior Manufacturing 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