Manager, Validation
About the role
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. 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. 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.
Responsibilities
- Manage validation activities that ensure product quality and regulatory compliance
- Develop validation strategy
- Oversee a 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
- Maintain the validated state of systems that help produce therapeutics
Requirements
- Bachelor's degree in engineering, science, chemistry, biology or related technical discipline. Advanced Degree preferred.
- 6 - 8 years of experience in pharmaceutical/biotech manufacturing industry.
- 2+ years of experience with equipment, process, cleaning, and/or utility validation is required.
- 3+ years of people management or team leadership experience.
- Demonstrated success managing complex validation projects and programs.
- Experience with validation master planning and change control systems.
- Experience participating in regulatory inspections and customer audits.
- Experience with smoke studies would be a plus.
Skills
- Strong knowledge of cGMP regulations, particularly FDA and EU requirements.
- Expertise in risk assessment methodologies and statistical analysis.
- 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.
Benefits
- Competitive salary
- Annual incentive bonus plan
- 401K with company match up to 6%
- Tuition reimbursement
- A range of other employee benefits