QA Engineer, Drug Substance

The QA Engineer, Drug Substance will serve as a Quality Assurance Specialist responsible for manufacturing quality assurance, working directly with Manufacturing staff during drug substance operations to support real-time decisions on quality requirements and deviations. This role fosters strong partnership and knowledge sharing between Manufacturing and Quality teams while providing coaching, guidance, and direction to Manufacturing, Quality Control, Supply Chain, and Facilities & Engineering staff on compliance, quality systems, day-to-day QA oversight, and issue resolution or mitigation. Additionally, this role participates in optimization or improvement initiatives and supports regulatory agency and third-party inspections.

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: https://www.fujifilm.com/us/en/about/region/careers

What You’ll Do

• Responsible for providing Quality oversight to ensure that Drug Substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Fujifilm requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
• Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA).
• Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
• Oversee and provide guidance during on-the-floor analytical testing.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Ensure that deviations from established procedures are investigated and documented per procedures.
• Alert senior management of quality, compliance, supply and safety risks.
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
• Identification and implementation of continuous improvement opportunities within our processes and systems.
• Support and represent manufacturing QA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
• Collaborative attitude with the willingness to work with global peers and cross-functional teams to build strong partnerships, influence compliant operations, and achieve company and department goals.
• Excellent oral and written communications skills and fluency in English.
• Attention to detail with strong organizational skills and a commitment to maintaining quality standards while following assignments through to completion.
• Problem solving & conflict resolution.
• Provide source of knowledge and possess ability to mentor job duties for less experienced team members.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11.
• Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition.
• Familiarity with Computer / Automation systems (MES, Delta-V, SAP, PI data historian)
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
• Experience participating in, managing, and responding to health authority inspections, partner, and corporate audits.

Minimum Qualifications

• Bachelor’s degree in Life Sciences or Engineering with 5+ years of applicable industry experience; OR,
• Master’s degree in Life Sciences or Engineering and 3+ years of applicable experience; OR,
• PhD in Life Sciences or Engineering and 1+ years of applicable experience.
• 2+ years of experience in GMP Quality Assurance and/or similar role.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.

Preferred Qualifications

• Prior Experience and Working knowledge of Trackwise, Veeva, and/or Kneat validation software.
• Knowledge of electronic batch records and review-by-exception practices.
• Prior experience and knowledge with Quality Risk Management principles.
• Advanced Understanding of drug substance manufacturing including cell culture, upstream processes, large scale recovery and/or downstream processes.
• Expertise in cGMP & FDA regulations.
• Experience with startup projects or initiatives.
• Occasional opportunity for International and/or Domestic travel may be available.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to:

• Ability to stand for prolonged periods of time for up to 30 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.

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.

*LI-Onsite

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.

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]).