QC Validation Engineer III

Thermo Fisher Scientific • Detroit, MI

1d • Onsite

About The Position

Location: Detroit, MI. Relocation assistance is NOT provided. 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 team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. A Day in the Life: Ensure product quality and regulatory compliance across pharmaceutical manufacturing operations. Lead complex validation projects for laboratory equipment, analytical test methods, equipment, processes, utilities, and computer systems Collaborate with cross-functional teams to maintain cGMP standards. Contribute to continuous improvement initiatives, support team members providing technical expertise. This role offers professional growth opportunities as you help enable life-changing therapies through robust validation strategies and execution. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

• Minimum Required Education: Bachelor of Science (BS) degree in Science or Technical field.
• 3+ years of validation experience in a lab environment
• Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirement
• Experience writing and executing validation protocols, including IQ/OQ/PQ documentation
• Expertise in risk assessment methodologies and statistical analysis
• Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
• Strong technical writing and documentation skills
• Advanced problem-solving abilities and root cause analysis experience
• Excellent verbal/written communication and interpersonal skills
• Proficiency with relevant software tools (MS Office, statistical packages, validation systems)
• Knowledge of lean manufacturing and continuous improvement methodologies
• Ability to work in cleanroom environments when required
• Flexibility to work extended hours or alternate shifts based on project needs
• May require travel on as needed basis
• Work requires standing for long durations, managing materials, and operating quality inspection instruments in a manufacturing setting.

Nice To Haves

• Manufacturing validation experience is a plus
• Experience leading complex validation projects and coordinating cross-functional teams
• Experience with regulatory inspections and client audits preferred

Responsibilities

• Ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.
• Lead complex validation projects for laboratory equipment, analytical test methods, equipment, processes, utilities, and computer systems
• Collaborate with cross-functional teams to maintain cGMP standards.
• Contribute to continuous improvement initiatives, support team members providing technical expertise.
• Enable life-changing therapies through robust validation strategies and execution.

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees