Quality Assurance Validation Manager
Thermo Fisher Scientific
Thermo Fisher Scientific seeks a Quality Assurance Validation Manager to lead validation programs at its sterile fill-finish facility in Ridgefield, New Jersey. The role oversees equipment, utilities, systems, and process validation while ensuring cGMP compliance and supporting cross-functional teams in manufacturing therapeutics and critical products.
Responsibilities
- Lead and oversee validation activities for manufacturing, laboratory, utility, facility, and computer systems
- Develop validation strategies, master plans, and project timelines in collaboration with stakeholders
- Coordinate planning, execution, review, and approval of validation protocols and reports
- Ensure compliance with cGMP requirements and applicable regulatory standards during validation activities
- Support regulatory inspections, customer audits, and quality assessments
Requirements
- Advanced degree with 8+ years validation experience, or bachelor's degree with 10+ years
- Background in engineering, chemistry, biology, life sciences, or related technical discipline
- Significant validation experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing
- Expertise in process validation, analytical instrument qualification, and validation master planning
- Proficiency in data integrity compliance, change control systems, and quality management systems
- Experience managing complex validation projects and leading cross-functional teams
- Knowledge of FDA, EU, and global regulatory requirements for pharmaceutical manufacturing
Vacancy posted 15 days ago
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