Facilities Quality And Compliance Specialist

Thermo Fisher Scientific UK

Middleton, Wisconsin, United States
Onsite
21 cfr compliance knowledge
Gmp regulated environment experience
Change control workflow management
Thermo Fisher Scientific is seeking a Facilities Quality and Compliance Specialist for their GMP Lab in Middleton, Wisconsin. This fully onsite role involves ensuring compliance with regulatory standards in facilities management and maintenance activities within a GMP environment

Job Summary

  • This role ensures that facilities and maintenance activities are planned, executed, and documented in a state of control and in compliance with 21 CFR and GMP requirements.
  • The position partners closely with Facilities, Maintenance, Engineering, Quality, and EHS teams to support audit readiness, change management, and lifecycle compliance of facility systems.
  • Thermo Fisher Scientific values the health and wellbeing of our employees and encourages individuals to create a healthy and balanced environment where they can thrive.

Matching Summary

Match Score: 85

Thermo Fisher Scientific is seeking a Facilities Quality and Compliance Specialist for their GMP Lab in Middleton, Wisconsin. This fully onsite role involves ensuring compliance with regulatory standards in facilities management and maintenance activities within a GMP environment.

Skills & Requirements

Must-have

  • 21 CFR compliance knowledge
  • GMP regulated environment experience
  • Change control workflow management
  • CMMS or CAFM system usage
  • Technical drawing and P&ID interpretation
  • Risk assessment and impact evaluation
  • Audit readiness and inspection support

Nice-to-have

  • Facilities commissioning qualification experience
  • Medical industry facilities background
  • Strong analytical and critical thinking skills
  • Ability to work collaboratively across functions
  • Comfort with ambiguity and uncertainty
  • Proactive identification of compliance gaps

Key Requirements

  • Bachelor's degree in science, engineering, quality, or related field
  • At least 3 years of relevant experience
  • Must be legally authorized to work in the United States without sponsorship
  • Pass comprehensive background check including drug screening
  • Experience in a regulated GMP environment

Work Rights

Must be legally authorized to work in the US without sponsorship

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