Validation Manager
Thermo Fisher Scientific
Validation Manager role overseeing qualification of equipment, utilities, facilities, and manufacturing processes to ensure product quality and regulatory compliance in a pharmaceutical manufacturing environment. Manages validation activities, develops strategy, and leads teams while supporting new product introductions and technology transfers.
Responsibilities
- Manage and oversee validation activities for equipment, utilities, facilities, and computer systems
- Develop validation strategy and master plans aligned with cGMP requirements
- Lead team responsible for qualifying manufacturing processes and systems
- Support regulatory inspections, customer audits, and change control processes
- Collaborate across functions to ensure validation activities support product introductions and technology transfers
Requirements
- 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
- Excellent technical writing and documentation skills
Vacancy posted a month ago
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