Validation Manager
Thermo Fisher Scientific
Summary
As a Validation Manager at Thermo Fisher Scientific, you will manage validation activities that ensure product quality and regulatory compliance. You'll develop validation strategy and oversee a team responsible for qualifying equipment, utilities, facilities, computer systems, and manufacturing processes.
Job description
A Day in the Life
- Working across functions, you'll ensure validation activities align with cGMP requirements while supporting new product introductions and technology transfers.
- This role offers the opportunity to make a meaningful impact by maintaining the validated state of systems that help produce therapeutics.
Keys to Success: Education/Experience
- Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6 years of experience in validation in pharmaceutical/biotech manufacturing or related regulated industry required.
- Preferred Fields of Study: Engineering, Science, Chemistry, Biology, or related technical discipline.
- 3+ years of people management or team leadership experience.
- Experience with equipment, process, cleaning, computer system, and utility validation - temperature mapping experience preferred
- Experience with data integrity evaluation and knowledge of ALCOA++ principles
- Experience participating in regulatory inspections and customer audits
- Experience with validation master planning and change control systems
Knowledge, Skills, Abilities
- Expertise in risk assessment methodologies and statistical analysis
- Demonstrated success managing complex validation projects and programs
- Strong knowledge of cGMP regulations, particularly FDA and EU requirements
- Proficiency with quality systems and validation documentation
- Excellent technical writing and documentation skills
- Strong leadership, communication, and interpersonal abilities
- Ability to influence and collaborate across functions and levels
- Knowledge of lean/continuous improvement methodologies
- Proficient with standard business software applications
- Travel up to 10% as needed
Requirements
- Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6 years of experience in validation in pharmaceutical/biotech manufacturing or related regulated industry required.
- Preferred Fields of Study: Engineering, Science, Chemistry, Biology, or related technical discipline.
- 3+ years of people management or team leadership experience.
- Experience with equipment, process, cleaning, computer system, and utility validation - temperature mapping experience preferred
- Experience with data integrity evaluation and knowledge of ALCOA++ principles
- Experience participating in regulatory inspections and customer audits
- Experience with validation master planning and change control systems
- Expertise in risk assessment methodologies and statistical analysis
- Demonstrated success managing complex validation projects and programs
- Strong knowledge of cGMP regulations, particularly FDA and EU requirements
- Proficiency with quality systems and validation documentation
- Excellent technical writing and documentation skills
- Strong leadership, communication, and interpersonal abilities
- Ability to influence and collaborate across functions and levels
- Knowledge of lean/continuous improvement methodologies
- Proficient with standard business software applications
- Travel up to 10% as needed
Benefits
- Healthcare
- Annual incentive plan bonus scheme
- Competitive remuneration
- Employee benefits
Company overview
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. The company's mission is to enable customers to make the world healthier, cleaner, and safer. With over 100,000 employees globally, Thermo Fisher provides an unrivaled combination of innovative technologies, purchasing convenience, and pharmaceutical services through its industry-leading brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. The company serves customers across healthcare, life sciences, applied markets, and pharmaceutical sectors, offering solutions that accelerate research, solve complex analytical challenges, improve patient diagnostics, and increase laboratory productivity. Headquartered in Waltham, Massachusetts, Thermo Fisher operates globally, delivering critical scientific products, services, and workflow solutions that support researchers, organizations, and companies in addressing some of the world's most pressing issues.