QA Engineer – Drug Substance Manufacturing

FUJIFILM Electronic Materials U.S.A., Inc.; Holly Springs (NC); On-site; USD 95,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer for DSM Operations to guide quality oversight from development through startup to commercial operation. The role ensures validation, lifecycle documentation, and QA support for manufacturing systems in a cGMP facility.

The candidate will collaborate with global sites, manage risk assessments, and participate in regulatory inspections while maintaining project timelines and readiness for 24/7 operations.

Qualifications

• BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable industry experience, OR;
• MS in Life Sciences or Engineering and 3+ years of applicable experience, OR;
• PhD in Life Sciences or Engineering with 1+ years of applicable experience.
• 3+ years of experience in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Responsibilities

• Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program.
• Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation.
• Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports.
• Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems.
• Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility.
• Ensures project and operational quality objectives are met within desired timelines.
• Collaborates and aligns with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency.
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections.
• Performs other duties as assigned.

Skills

QA Oversight

Documentation

Regulatory

cGMP

Validation

GAMP5

Data Integrity

Change Management

Communication

Collaboration

Education

BS/BA Life Sciences or Engineering

MS Life Sciences or Engineering

PhD Life Sciences or Engineering

GMP Experience

Tools

Trackwise

MasterControl

Kneat

Smartsheet

ASTM E2500

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer for DSM Operations to guide quality oversight from development through startup to commercial operation. The role ensures validation, lifecycle documentation, and QA support for manufacturing systems in a cGMP facility.

The candidate will collaborate with global sites, manage risk assessments, and participate in regulatory inspections while maintaining project timelines and readiness for 24/7 operations.