QA Engineer, DSM Operations

Position Overview

The QA Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes through to operational readiness during project phase. This role is responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues. This role works 12-hour day shift on a 2-2-3 cadence, 0600-1800 (Days).

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Job Description

What You'll Do

• 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 a cGMP-regulated facility
• Ensures project and operational quality objectives are met within desired timelines
• Collaborates and aligns with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency
• Participates in optimization or improvement initiatives and support regulatory agency and third-party inspections
• Works 12-hour shift on 2-2-3 cadence, 0600-1800
• Performs other duties as assigned

Minimum Requirements:

• 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 and with 1+ years of applicable experience
• 3+ years of experience working in a GMP regulated environment
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility

Preferred Requirements:

• Working knowledge and experience with ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software
• Experience with startup projects or initiatives

Working Conditions & Physical Requirements:

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. No X Yes Daily for 30 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to sit for prolonged periods of time. No X Yes Daily for 120 minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
minutes)
Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. X No Yes

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).