QA Engineer, DSM Operations - Nights (2 Openings)

Position Overview

The QA Engineer, DSM Operations (Night) is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing processes during the night shift. This role collaborates within the DSM Quality team as well as with other cross-functional teams. Ensures that all DSM systems and processes are operated/maintained as intended, with a focus on consistent policy administration, QA oversight of activities occurring during your shift and resolution or mitigation of issues occurring during operation. 

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

 

Join us

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.

 

Job Description

What You'll Do

 

• Perform an SME role within the QA team for the development of documents, processes, and procedures for the DSM program• Per applicable procedures, provides QA support of tasks such as BPR review, event triage, DR/CAPA review and approval, area changeover and release and WO oversight• 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 documentation, procedures, and processes for QA support of manufacturing operations in cGMP regulated facility• Ensures operational quality objectives are met within desired timelines• Participates in optimization or improvement initiatives• Actively seeks opportunities to collaborate and align with other FUJIFILM Diosynth Biotechnologies sites to streamline processes and maximize efficiency• Perform other duties as assigned

 

Minimum Requirements:

 

• BS/BA in Life Sciences or Engineering or equivalent with 6+ years of applicable industry experience OR• MS in Life Sciences or Engineering and 4+ years of applicable experience OR• PhD in Life Sciences or Engineering and without any 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, and methodologies• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11

 

Preferred Requirements:

 

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

• Training and/or familiarity with Quality Risk Management principles

 

Physical and Work Environment Requirements:

 

Ability to discern audible cues.

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 activities using repetitive motions that include writs, hands and/or fingers.

Ability to conduct work that includes moving objects up to 10 pounds.

Will work in warm/cold environments

Will work in small and/or encl