Manufacturing Validation Supervisor

Work Schedule

Environmental Conditions

Job Description

Location: Grand Island NY. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States withoutsponsorship.

*Must be able to pass a comprehensive background check whichincludes a drug screening.

As part of theThermoFisher Scientific teamyoulldiscover 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 healthiercleanerand safer. We provide our global teams with the resources needed to achieve individual career goals while helping to takesciencea step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Discover Impactful Work:

Thermo Fisher Scientific is seeking a highly motivated and experienced Validation Engineering Supervisor to lead and transform the validation organization at our Grand Island (GI) site. This leadership role is responsible for building and overseeing a world-class risk-based and scalable validation function that supports operational excellence compliance readiness and strategic growth initiatives.

A Day in the Life:

The successful candidate will lead a cross-functional validation team responsible for process validation equipment/system qualification metrology and validation execution activities while partnering closely with Manufacturing Engineering Quality and Global Validation stakeholders. They will be responsible for leading the validation organization driving validation excellence supporting operational and compliance goals and providing technical oversight.

What Will You Do:

• Supervise and develop a team of validation engineers metrology personnel and validation technicians.
• Set priorities allocate resources and manage execution of validation projects and site initiatives.
• Provide coaching mentorship and career development opportunities for team members.
• Promote a culture of accountability collaboration and continuous improvement.
• Establish and maintain risk-based validation strategies aligned with regulatory and global standards.
• Govern site-wide validation programs including process equipment utility and system validation activities.
• Ensure consistency and standardization of validation methodologies documentation and execution practices.
• Support global alignment and knowledge-sharing initiatives across validation networks.
• Accelerate product and process changes through efficient validation execution.
• Strengthen inspection readiness and ensure compliance with GMP FDA ISO and internal quality requirements.
• Reduce variability and redundancy in validation processes while improving operational efficiency.
• Review and approve validation protocols reports deviations risk assessments and change controls.
• Oversee Process Validation activities to ensure manufacturing processes consistently meet defined requirements.
• Direct Equipment/System Validation efforts including IQ/OQ/PQ execution.
• Ensure metrology and calibration systems maintain reliable and compliant measurements.
• Coordinate technician support for validation studies and field execution activities.
• Partner with local and global teams to support strategic initiatives and site priorities.
• Participate in audits inspections investigations and continuous improvement programs.
• Position the GI site as a center of excellence within the global validation organization.

How Will You Get Here

Education:

• Minimum Education Required: Bachelors degree in Engineering Life Sciences or a related technical discipline.

Experience:

• Experience Required: 3-5 years of experience in validation engineering manufacturing or quality.
• Prior leadership or supervisory experience preferred.
• Experience in biopharmaceutical medical device or life sciences manufacturing preferred.
• Lean Six Sigma or continuous improvement experience preferred.
• Experience supporting regulatory inspections and audits preferred.

Knowledge Skills Abilities:

• Strong knowledge of:
  • GMP regulations
  • Process Validation
  • Equipment Qualification (IQ/OQ/PQ)
  • Risk-based validation principles
  • Change control deviations and CAPA systems
  • Metrology and calibration practices
• Excellent organizational communication and problem-solving skills.
• Knowledge of global validation lifecycle management practices preferred.

Benefits

We offer competitive compensation annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 140000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager