Senior QA Validation Engineer for Biotech Systems

Socket.dev; Holly Springs (NC); On-site; USD 110,000 - 165,000; Full time

Job summary

Fujifilm Biotechnologies in Holly Springs, NC is seeking a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities in a cGMP facility.

You will review and approve validation documents, oversee change management, and ensure equipment/processes stay in a validated state, with 24/7 support as needed. The role emphasizes collaboration with global peers and regulatory readiness.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 5 years of industry experience, or
• Master’s degree with 3 years, or PhD with 1 year of experience in GMP environments.
• 3+ years of experience in a GMP regulated environment.
• Experience in Validation and/or Quality oversight in an FDA-regulated facility.

Responsibilities

• Oversee development and approval of validation documents, risk assessments, user requirements, and specifications.
• Review lifecycle documentation including protocols, validation plans, and summary reports.
• Provide QA procedures for validation approaches and lifecycle documents.
• Support manufacturing operations QA with compliant documentation and processes.
• Assist in regulatory inspections and 3rd party audits.

Skills

Communication

English fluency

Time management

Critical thinking

Collaboration

cGMP knowledge

Genki culture

Education

Bachelor’s degree in Life Sciences or Engineering

Master’s degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

ASTM E2500

Smartsheets

Trackwise

Veeva

Kneat validation software

Job description

Fujifilm Biotechnologies in Holly Springs, NC is seeking a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities in a cGMP facility.

You will review and approve validation documents, oversee change management, and ensure equipment/processes stay in a validated state, with 24/7 support as needed. The role emphasizes collaboration with global peers and regulatory readiness.