QA Engineer, DSM Operations

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 5 days ago

Vacancies: 1 Vacancy

Job Summary

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What Youll 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
minutes)
Ability to sit for prolonged periods of time. No X Yes Daily for 120 minutes (If yes may specify frequency/duration: up to
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 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 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.

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 ().

Required Experience:

Position OverviewThe 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 activ...