Facilities Specialist I/II - Quality and Compliance - GMP Lab

Regulatory Jobs; Town of Middleton (WI); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific in Middleton, WI is seeking a facilities compliance professional to lead GMP-aligned maintenance and qualification activities. You will partner with Facilities, Maintenance, Engineering, Quality, and EHS to ensure lifecycle compliance of facility systems.

The role requires a Bachelor's degree and 2+ years of relevant experience, with strong problem-solving and communication skills. This is a fully onsite opportunity with a focus on audit readiness and change management.

Formación

• Bachelor's degree or equivalent.
• 2+ years of relevant experience.
• Equivalency may be considered with education and training.

Responsabilidades

• Ensure facilities and maintenance activities are planned, executed, and documented in a controlled state.
• Manage Change Controls related to facilities and infrastructure, including risk assessments.
• Support audits and regulatory inspections and address audit findings and remediation actions.
• Review CQV documentation and drawing validation for traceability and lifecycle compliance.
• Interact with vendors and internal customers to maintain compliance and contracts.

Conocimientos

Problem solving

Communication

Microsoft Office

Vendor interaction

Multitasking

Educación

Bachelor's degree

Herramientas

CMMS/CAFM systems

Descripción del empleo

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

This is a fully onsite role based at our 8551 Research Way Suite 90 location in Middleton, WI. 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.

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

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.

A Day in the Life:

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

Keys to Success:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
• 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:

• Proven ability to handle multiple tasks simultaneously and balance priorities
• Strong problem-solving skills
• Strong computer skills in Microsoft Office Suite
• Effective oral and written communication skills
• Basic understanding of building systems (mechanical, electrical, security, etc.)
• Knowledge of electrical, plumbing, mechanical and/or light general construction may be required
• Ability to effectively interact with outside vendors and internal customers
• Positive attitude and ability to work well with others
• Comfort with ambiguity and effectiveness during periods of uncertainty and change
• May require knowledge and understanding of computerized maintenance and work order systems
• May require a strong understanding of security systems

Working Conditions and Environment:

• 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 lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.