QA Validation Engineer – Biotech GMP (24/7 Support)

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities. You will review and approve validation documents, maintain validated states, and ensure lifecycle integrity across facilities and equipment.

The role requires robust GMP experience, strong English communication, and collaboration with global teams. Occasional travel may be required to support regulatory inspections and process improvements.

Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 5 years of applicable industry experience; OR, Master’s with 3 years; OR, PhD 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.
• Strong verbal and written communication skills in English.
• Willingness to travel internationally and/or domestically.

Responsibilities

• Performs SME role within the QA team for development of Validation program documents, processes, and procedures.
• Assesses impact of system and process changes; maintains change management oversight to validate facilities, utilities, and equipment.
• Oversees and approves lifecycle documents: risk assessments, user requirements, specs, traceability matrices, validation plans, and summaries.
• Generates and approves QA procedures for validation approaches and lifecycle documents.
• Generates/ Reviews QA documentation for QA support of manufacturing operations in a cGMP facility.
• Ensures project and operational quality objectives are met within timelines.
• Supports 24/7 manufacturing operations as needed.
• Participates in optimization initiatives and regulatory inspections.

Skills

QA oversight

Validation documents

Change control

Communication skills

Problem solving

Team collaboration

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

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer, Validation to drive quality oversight for commissioning and qualification activities. You will review and approve validation documents, maintain validated states, and ensure lifecycle integrity across facilities and equipment.

The role requires robust GMP experience, strong English communication, and collaboration with global teams. Occasional travel may be required to support regulatory inspections and process improvements.