QA Engineer – Drug Substance Ops & Validation Lead

FUJIFILM; Holly Springs (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer for the DSM Operations team. The role focuses on quality oversight of drug substance manufacturing processes from project initiation through startup and commercial operation, including validation and change control.

The candidate will approve documentation, support regulatory inspections, and collaborate across FUJIFILM sites to improve processes. This on-site role requires a 12-hour day shift with a 2-2-3 cadence.

Qualifications

• BS/BA with 5+ years GMP experience or MS with 3+ years, or PhD with 1+ year in a GMP setting.
• Experience in Validation, GMP manufacturing operations and quality oversight in an FDA-regulated facility.

Responsibilities

• Provide QA oversight of DSM program documents, processes, and procedures.
• Assess impact of system and process changes and maintain validated state.
• Approve lifecycle documentation, risk assessments, specs, and validation reports.
• Generate and approve QA procedures for validation approaches and lifecycle documents.
• Support QA in manufacturing operations and regulatory inspections.

Skills

GMP compliance

Validation

Quality oversight

CFR Part 11

Problem solving

Cross-functional collaboration

Documentation quality

English proficiency

Project coordination

Education

BS/BA in Life Sciences or Engineering

MS in Life Sciences or Engineering

PhD in Life Sciences or Engineering

Tools

Smartsheet

Trackwise

MasterControl

Kneat validation

ASTM E2500 knowledge

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer for the DSM Operations team. The role focuses on quality oversight of drug substance manufacturing processes from project initiation through startup and commercial operation, including validation and change control.

The candidate will approve documentation, support regulatory inspections, and collaborate across FUJIFILM sites to improve processes. This on-site role requires a 12-hour day shift with a 2-2-3 cadence.