Manager, Validation

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
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.
DESCRIPTION:
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.
EDUCATION/EXPERIENCE:
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
KNOWLEDGE, SKILLS, ABILITIES:
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
NOTE: We are not able to offer relocation assistance or visa sponsorship for this role at this time. We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team. We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!