Manager, Validation
Thermo Fisher Scientific · Greenville, NC
QualityFull timeCompany career page
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Validation Manager position overseeing validation activities for pharmaceutical manufacturing systems and processes. The role involves managing a team to ensure product quality, regulatory compliance, and alignment with cGMP requirements across equipment, utilities, facilities, and computer systems.
What they're looking for
- Bachelor's degree in engineering, science, chemistry, biology, or related technical field
- 6–8 years pharmaceutical or biotech manufacturing industry experience
- 2+ years equipment, process, cleaning, and/or utility validation experience
- 3+ years people management or team leadership experience
- Strong knowledge of cGMP regulations (FDA and EU requirements)
- Expertise in risk assessment methodologies and statistical analysis
- Experience with validation master planning and change control systems
What you'll be doing
- Manage validation activities and develop validation strategy for product quality and regulatory compliance
- Oversee team responsible for qualifying equipment, utilities, facilities, computer systems, and manufacturing processes
- Ensure validation activities align with cGMP requirements while supporting new product introductions and technology transfers
- Participate in regulatory inspections and customer audits
- Collaborate across functions to maintain validated state of systems
Privacy & handoff
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