Validation Manager: Lead Quality & Compliance in Pharma

RXinsider LTD.; Greenville, Northern (NC, KY); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Annual bonus

401K match

Tuition reimbursement

Job summary

Thermo Fisher Scientific in Greenville, NC is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance. You will develop validation strategy and oversee validation of equipment, utilities, facilities, computer systems, and manufacturing processes.

Collaborating across functions, you’ll ensure alignment with cGMP requirements, support new product introductions and technology transfers, and maintain validated states of systems enabling

Qualifications

• Bachelor's degree in engineering, science, chemistry, biology or related technical discipline. Advanced Degree preferred
• 6-8 years of experience in pharmaceutical/biotech manufacturing industry
• 2+ years of experience with equipment, process, cleaning, and/or utility validation is required.
• 3+ years of people management or team leadership experience
• Demonstrated success managing complex validation projects and programs
• 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 that ensure product quality and regulatory compliance
• Develop validation strategy and oversee validation of equipment, utilities, facilities, computer systems, and manufacturing processes
• Work across functions to ensure validation activities align with cGMP requirements
• Support new product introductions and technology transfers
• Maintain the validated state of systems that help produce therapeutics

Skills

cGMP knowledge

FDA/EU regulations

risk assessment

quality systems

technical writing

leadership

cross-functional collaboration

lean/continuous improvement

communication

proficient software

Education

Bachelor's degree in engineering/technical discipline

Advanced degree preferred

Job description

Thermo Fisher Scientific in Greenville, NC is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance. You will develop validation strategy and oversee validation of equipment, utilities, facilities, computer systems, and manufacturing processes.

Collaborating across functions, you’ll ensure alignment with cGMP requirements, support new product introductions and technology transfers, and maintain validated states of systems enabling