Validation Manager
Thermo Fisher Scientific Inc
Validation Manager position at Thermo Fisher Scientific's Clinical Trials Division in Allentown, Pennsylvania. Responsible for managing validation activities across equipment, utilities, facilities, and manufacturing processes to ensure product quality and regulatory compliance while leading a validation team.
Responsibilities
- Manage validation activities and develop validation strategy across multiple system types
- Oversee team responsible for qualifying equipment, utilities, facilities, and systems
- Ensure validation activities align with cGMP requirements and regulatory compliance
- Support new product introductions and technology transfers
- Participate in regulatory inspections and customer audits
Requirements
- Advanced degree plus 4 years validation experience, or bachelor's degree plus 6 years in pharmaceutical/biotech manufacturing
- 3+ years people management or team leadership experience
- Equipment, process, cleaning, computer system, and utility validation experience
- Knowledge of ALCOA++ principles and data integrity evaluation
- Strong cGMP regulations knowledge, particularly FDA and EU requirements
- Risk assessment methodologies and statistical analysis expertise
- Experience with validation master planning and change control systems
Vacancy posted 7 days ago
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