Validation Supervisor

Thermo Fisher Scientific•Grand Island, NY

13d•Onsite

About The Position

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. 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.

Requirements

Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
3-5 years of experience in validation, engineering, manufacturing, or quality.
Strong knowledge of GMP regulations
Strong knowledge of Process Validation
Strong knowledge of Equipment Qualification (IQ/OQ/PQ)
Strong knowledge of Risk-based validation principles
Strong knowledge of Change control, deviations, and CAPA systems
Strong knowledge of Metrology and calibration practices
Excellent organizational, communication, and problem-solving skills.

Nice To Haves

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 of global validation lifecycle management practices preferred.

Responsibilities

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.

Benefits

Competitive compensation
Annual incentive plan bonus
Healthcare
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
Short- and long-term disability
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