QA Engineer DSM Operations - Nights

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 crossfunctional 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.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

Perform an SME role within the QA team for the development of documents processes and procedures for the DSM program (Working Schedule:in a 223 cadence)

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 enclosed spaces.

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 viaemail 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.

Fujifilm is committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .