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