Facilities Quality and Compliance Specialist

Thermo Fisher Scientific•Middleton, WI

1d•Onsite

About The Position

This position supports the Facilities function for the Middleton Site, providing compliance oversight, guidance, and subject matter expertise for facilities, maintenance, construction, and infrastructure activities within a CFR-regulated GMP environment. The role ensures that all facilities and maintenance activities are planned, executed, and documented in a controlled state, adhering to 21 CFR, GMP requirements, and internal quality systems. The Facilities Quality and Compliance Specialist collaborates closely with Facilities, Maintenance, Engineering, Quality, and EHS teams, focusing on audit readiness, change management, and lifecycle compliance of facility systems. The ideal candidate possesses experience working with Facilities and Maintenance teams in a regulated GMP setting, with a primary focus on compliance oversight, documentation, and audit readiness, rather than direct maintenance execution.

Requirements

Bachelor’s degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 3 years).
Experience in a regulated environment with exposure to facilities, utilities, engineering, maintenance, or quality compliance.
Direct experience supporting facilities, utilities, or infrastructure systems that impact GMP operations.
Ability to read and understand technical drawings, P&IDs, and system schematics.
Practical understanding of 21 CFR requirements as they apply to facilities, maintenance, and support systems.
Strong understanding of change control flow, approval requirements, and downstream impacts.
Experience evaluating risk to operations when facilities systems are modified or maintained.
Experience working with CMMS or CAFM systems from a compliance perspective.
May need to climb ladders for roof access.
Must be able to wear Personal Protective Equipment while carrying out work tasks.
Must be able to wear fall protection.
Demonstrates a strong compliance and risk-based mindset.
Maintains independence while collaborating effectively with execution teams.
Communicates clearly and professionally across functions.
Proactively identifies compliance gaps and improvement opportunities.
Manages multiple priorities while maintaining attention to detail.
Exercises sound judgment in regulated environments.
Manages time and performs within required deadlines, managing business priorities.
Exhibits strong analytical and critical thinking and decision-making skills.
Curiosity and willingness to learn and adapt to new tactics and strategies.
Comfort with ambiguity and effectiveness during periods of uncertainty and change.
Able to participate in complex meetings with multiple attendees, and work collaboratively to identify and resolve complex issues, building effective working relationships, and participate in process improvement.
Able to plan for contingencies to overcome obstacles, setbacks and uncertainties to ensure delivery of results.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

Degree field in science, engineering, quality, facilities, or a related field preferred.
Technology or medical industry facilities experience is preferred.

Responsibilities

Provide compliance oversight for facilities, utilities, and maintenance activities impacting GMP-regulated spaces, ensuring alignment with 21 CFR, GMP requirements, and internal SOPs.
Partner with Facilities and Maintenance teams to ensure compliant use of CMMS / CAFM systems, accurate recordkeeping, and effective lifecycle documentation.
Author, manage, and assess Change Controls related to facilities, utilities, and infrastructure, including completion of risk assessments, and impact evaluations.
Ensure appropriate risk assessments and impact evaluations are completed and documented.
Understand CC workflows, approval requirements, and downstream impacts.
Support deviation investigations, CAPA development, and effectiveness checks related to facilities compliance issues.
Support internal and external audits and regulatory inspections, including resolution of QA audit findings, inspection responses, remediation plans, and follow-up actions.
Support drawing validation and documentation traceability related to facility systems.
Provide compliance guidance for facilities-related commissioning, qualification, and validation activities as needed, including review of CQV documentation and drawing validation to ensure traceability and risk-based lifecycle compliance.
Partner with Procurement to support maintenance contracts, including development of task lists and adherence to contract requirements and KPIs.
Ensure all work is performed in a timely, professional manner and in compliance with OSHA, EHS, and organizational policies, maintaining required training and readiness.
Provide daily operational compliance support and perform additional related duties as assigned.