Location: Grand Island, NY. Relocation assistance is NOT provided.
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.
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.
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: Bachelor’s 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.
