Validation Manager — GMP & Tech Transfer Leader

Regulatory Jobs; Greenville (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

401K match

Tuition reimbursement

Benefits package

Job summary

Thermo Fisher Scientific is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance. You will develop validation strategy and oversee qualification of equipment, utilities, facilities, computer systems, and manufacturing processes, aligning with cGMP and supporting tech transfers.

Experience in regulatory inspections and audits is valued, with 2+ years in team leadership.

Qualifications

• Bachelor's degree in engineering or related technical field.
• 6-8 years in pharmaceutical/biotech manufacturing.
• 2+ years validating equipment/process/utility.
• 3+ years people management or team leadership.
• 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.

Responsibilities

• Manage validation activities for product quality and regulatory compliance.
• Develop validation strategy and oversee qualification of equipment, utilities, facilities, computer systems and manufacturing processes.
• Ensure validation activities align with cGMP requirements and support tech transfers.
• Maintain the validated state of systems that help produce therapeutics.

Skills

cGMP knowledge

risk assessment

statistical analysis

documentation skills

leadership

cross-functional collaboration

Education

Bachelor's degree in engineering/science

Advanced degree preferred

Job description

Thermo Fisher Scientific is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance. You will develop validation strategy and oversee qualification of equipment, utilities, facilities, computer systems, and manufacturing processes, aligning with cGMP and supporting tech transfers.

Experience in regulatory inspections and audits is valued, with 2+ years in team leadership.