QA Engineer: Drug Substance Manufacturing & Validation

FUJIFILM Holdings America Corporation; Holly Springs (NC); On-site; USD 90,000 - 140,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Engineer, QA Drug Substance Manufacturing to drive quality oversight of the DSM program from development through startup and into commercial operation.

The role provides oversight of system and process validation, change control, and lifecycle documentation, ensuring cGMP compliance and readiness across manufacturing systems; travel may be required. Strong communication and cross-functional collaboration are essential.

Qualifications

• BS/BA in Life Sciences or Engineering plus 5+ years in a GMP/QA role or advanced degrees with corresponding experience.

Responsibilities

• Serve as SME in QA for DSM document/process development and lifecycle oversight.
• Assess impact of system/process changes and ensure validated state through startup to commercial operation.
• Approve lifecycle documentation, risk assessments, and validation plans/reports.
• Develop and approve QA procedures for validation approaches and lifecycle documents.
• Provide QA support for manufacturing operations in a cGMP facility and ensure timely quality objectives.
• Collaborate with FUJIFILM Biotechnologies sites to improve processes and efficiency.
• Support regulatory inspections and participate in improvement initiatives.
• Perform other duties as assigned.

Skills

Communication

English fluency

Problem solving

Validation knowledge

GMP compliance

Cross-functional collaboration

Life sciences background

cGMP & FDA understanding

Teamwork

Education

BS/BA Life Sciences or Engineering

MS Life Sciences or Engineering

PhD Life Sciences or Engineering

Tools

Trackwise

MasterControl

Smartsheet

Kneat

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Engineer, QA Drug Substance Manufacturing to drive quality oversight of the DSM program from development through startup and into commercial operation.

The role provides oversight of system and process validation, change control, and lifecycle documentation, ensuring cGMP compliance and readiness across manufacturing systems; travel may be required. Strong communication and cross-functional collaboration are essential.