Facilities Quality and Compliance Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position: Facilities Quality and Compliance Specialist

Location: Middleton, Wisconsin

Department: Facilities

This is a fully onsite role based at our GMP Lab in Middleton, Wisconsin. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  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. 

Position Summary: 

This position will support the Facilities function for the Middleton Site and provide compliance oversight, guidance, and subject matter expertise for facilities, maintenance, construction, and infrastructure activities within a CFR-regulated GMP environment.

This role ensures that facilities and maintenance activities are planned, executed, and documented in a state of control and in compliance with 21 CFR, GMP requirements, and internal quality systems. The position partners closely with Facilities, Maintenance, Engineering, Quality, and EHS teams and supports audit readiness, change management, and lifecycle compliance of facility systems.

The ideal candidate has experience working alongside Facilities and Maintenance teams in a regulated GMP environment, with responsibility for compliance oversight, documentation, and audit readiness, rather than execution of maintenance work.

Role 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.

• Daily operational support and other duties as needed or assigned.

Qualifications:

• Bachelor’s degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 3 years).

• Degree field in science, engineering, quality, facilities, or a related field preferred.

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• 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

• Technology or medical industry facilities experience is preferred

• 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

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

• Able to work upright and stationary and/or standing for typical working hours.

• Able to move effectively throughout facility, including lifting and moving objects up to 35-50 pounds.

• Able to work in non-traditional work environments.

• Able to use and learn standard office equipment and technology with proficiency.

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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