Senior QA Validation Engineer: CQV Leader

Socket.dev; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking a Senior QA Engineer, Validation to drive QA oversight for CQV activities and ensure ongoing validated state of equipment and processes. The role collaborates with regulators, clients, and management, and may involve domestic or international travel.

You will oversee lifecycle documentation, develop QA procedures, mentor team members, support inspections, and push continuous improvement while adhering to GMP and 21 CFR Part 820/11.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 8+ years of experience, or higher degrees with fewer years.
• 4+ years of experience in a GMP regulated environment.
• Experience in Commissioning, Qualification, and Validation (CQV) and Quality oversight, in an FDA regulated facility.
• Experience with CQV processes and validation documentation review.

Responsibilities

• Serve as QA CQV SME with regulators, clients, and management.
• Oversee change management to ensure facilities, utilities and equipment are validated and maintained.
• Review and approve lifecycle documentation, risk assessments, and validation plans/reports.
• Develop and approve QA procedures for validation approaches and lifecycle documents.
• Ensure completion of project and quality objectives within timelines.
• Provide shop floor QA support for issue resolution and escalation.
• Mentor less experienced team members and share technical guidance.
• Performs other duties as assigned.

Skills

GMP compliance

CQV knowledge

Regulatory oversight

Change management

Documentation review

Team leadership

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Trackwise

Veeva

Kneat

Smartsheets

ASTM E2500

Job description

Fujifilm Biotechnologies in Holly Springs, NC is seeking a Senior QA Engineer, Validation to drive QA oversight for CQV activities and ensure ongoing validated state of equipment and processes. The role collaborates with regulators, clients, and management, and may involve domestic or international travel.

You will oversee lifecycle documentation, develop QA procedures, mentor team members, support inspections, and push continuous improvement while adhering to GMP and 21 CFR Part 820/11.