Validation QA Engineer - cGMP Systems

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Engineer, Validation to lead quality oversight for commissioning and qualification activities, review and approve validation documents, and maintain validated state of equipment and processes.

You will collaborate with cross-functional teams in a 24/7 GMP facility, support regulatory inspections, and drive improvements while ensuring compliance with 21 CFR Part 11 and GAMP5.

Qualifications

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

Responsibilities

• Develop QA documentation and validation lifecycle approaches for facilities, utilities and equipment.
• Oversee change management and ensure validated state of systems and processes.
• Review and approve validation plans, protocols, and summary reports.
• Provide QA oversight for manufacturing operations in a cGMP facility.
• Support regulatory inspections and third-party audits.

Skills

Communication

English proficiency

GMP compliance

Validation practices

Documentation review

Education

Bachelor's degree in Life Sciences or Engineering

Master's degree in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Smartsheets

Trackwise

Veeva

Kneat validation software

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a QA Engineer, Validation to lead quality oversight for commissioning and qualification activities, review and approve validation documents, and maintain validated state of equipment and processes.

You will collaborate with cross-functional teams in a 24/7 GMP facility, support regulatory inspections, and drive improvements while ensuring compliance with 21 CFR Part 11 and GAMP5.