QA Engineer - DSM - Fujifilm

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The Quality Assurance Operations Engineer DSM is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes through to operational readiness during project phase. This role will be responsible for quality assurance oversight of day-to-day activities and resolution or mitigation of issues. 

• Perform an SME role within the QA Team for the development of documents, processes, and procedures for the DSM program.

• Assess the impact of system and process modifications and main 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.

• Provide 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.

• Generate, review, and approve QA procedures for the validation approach and lifecycle documents for manufacturing systems.

• Generate, revie, and approve QA documentation procedures and processes for operational readiness objectives and QA support of manufacturing operations in cGMP facility.

• Ensure that project and operational quality objectives are met within desired timelines.

• Collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiencies.

• Participate in optimization or improvement initiatives and support regulatory agency and third-party inspections.

• Perform other duties as assigned.

Minimum Requirements

• 6+ years of applicable industry experience

• 3+ 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

• High level of familiarity/understanding of validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT systems & methodologies

• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11

• Excellent Oral and Written communication skills and fluency in English

• BS/BA in Life Sciences or Engineering

Preferred Requirements

• MS in Life Sciences or Engineering and 4+ years of applicable experience

• PhD in Life Sciences or Engineering and without any experience  years of applicable experience

• Working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software

• Understanding of cell culture, upstream processes, large scale recovery and/or downstream processes

• Experience with startup projects or initiatives

• Fully embraces a Genki culture, able to bring positive energy to a dynamic work environment.

Occasional opportunity for International and/or Domestic travel may be available

PHYSICAL DEMANDS

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

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

• Ability to conduct work that includes moving up to 10 lbs