Validation QA Engineer: Quality Oversight (24/7)
FUJIFILM Biotechnologies
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Job summary
FUJIFILM Biotechnologies in North Carolina is seeking a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities across new and existing systems.
You will lead the preparation and review of validation plans, protocols, and reports, assess changes, and ensure facilities, utilities, and equipment remain in a validated state.
Strong communication, GMP experience, and flexibility to support a 24/7 manufacturing environment are essential.
Qualifications
- Bachelor’s degree in Life Sciences or Engineering with 5+ years in GMP.
- We’ll include Master’s degree with 3+ years in GMP.
Responsibilities
- Lead SME for Validation program documentation and procedures.
- Oversee change management and validation of facilities, utilities, and equipment.
- Review and approve validation plans, protocols, and reports.
- Develop QA procedures for validation approaches and lifecycle documents.
- Provide QA support for manufacturing operations in cGMP facilities.
- Coordinate readiness for regulatory inspections and audits.
- Support 24/7 manufacturing operations as needed.
- Collaborate with global teams to achieve quality objectives.
Skills
Education
Tools
Job description
FUJIFILM Biotechnologies in North Carolina is seeking a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities across new and existing systems.
You will lead the preparation and review of validation plans, protocols, and reports, assess changes, and ensure facilities, utilities, and equipment remain in a validated state.
Strong communication, GMP experience, and flexibility to support a 24/7 manufacturing environment are essential.
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