Validation Manager: Lead GMP Validation & Compliance

ThermoFisher Scientific; Greenville (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Annual incentive bonus

401K with company match up to 6%

Tuition reimbursement

Career development opportunities

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 a team qualifying equipment, utilities, facilities, computer systems and manufacturing processes.

In this role you will ensure alignment with cGMP requirements, support new product introductions and technology transfers, and maintain the validated state of systems that produce therapeutics.

Qualifications

• Bachelor’s degree in engineering, science, chemistry, biology or related technical discipline; advanced degree preferred.
• 6–8 years of pharma/biotech manufacturing experience.
• 2+ years leading validation or related activities.
• 3+ years of people management or team leadership experience.
• Experience with validation master planning and change control systems.
• Experience with regulatory inspections and audits.

Responsibilities

• Manage validation activities to ensure product quality and regulatory compliance.
• Develop validation strategy and oversee a team responsible for qualifying equipment, utilities, facilities, computer systems and processes.
• Ensure validation activities align with cGMP requirements across functions.
• Support new product introductions and technology transfers.
• Maintain the validated state of systems used to produce therapeutics.

Skills

Leadership

cGMP knowledge

Risk assessment

Statistical analysis

Documentation

Cross-functional collaboration

Communication

Lean/Continuous improvement

Education

Bachelor's degree in engineering/science/chemistry/biology or related technical discipline

Advanced Degree preferred

Tools

Quality systems

Change control systems

Statistical software

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 a team qualifying equipment, utilities, facilities, computer systems and manufacturing processes.

In this role you will ensure alignment with cGMP requirements, support new product introductions and technology transfers, and maintain the validated state of systems that produce therapeutics.