Senior QA Engineer, Digital Technologies

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The QA Engineer Digital Technologies is responsible for partnering in the Quality oversight of IT and Automation (OT) systems and provides oversight of validation program execution for these systems. This role collaborates within the Digital Technologies (DT) Quality team as well as with other project teams and with QA departments at other sites with a focus on consistent policy administration QA oversight of day-to-day activities and resolution or mitigation of issues occurring during operation.

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

During the project phase partners in the Quality oversight of IT and Automation (OT) systems through to operational readiness as well as provide oversight of validation program execution for these systems
Provides QA oversight and support of project deliverables in accordance with governing processes and procedures for the DT program
Assesses the impact of system and process modifications and maintain 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 IT and Automation (OT) systems
Generates reviews and approves QA documentation procedures and processes for operational readiness objectives and QA support of manufacturing operations in 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
Develops and supports start up activities into operations as the project matures such as system optimization or improvement initiatives and supporting regulatory agency and third-party inspections
Performs other duties as assigned

Minimum Requirements:

Bachelors in related science field with 5 years applicable experience OR
Masters in related science field. With 3 years applicable experience OR
PhD and 1 years 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
Experience and working knowledge of ASTM E2500 CSV/CSA and ALCOA

Preferred Requirements:

3 years of experience in a GMP quality assurance (QA) role with oversight of IT GxP systems validation and lifecycle.
Prior experience with Smartsheet and electronic validation software (e.g. Kneat).
Previous experience with the following processes preferred:
- Infrastructure (IT and/or OT related) Manufacturing Automation (e.g. DeltaV DCS DeltaV MES PI System PAS-X MES)

Working Conditions & Physical Requirements:

Ability to ascend or descend ladders scaffolding ramps etc. X No Yes

Ability to stand for prolonged periods of time. minutes)

No X Yes Daily for 60 minutes (If yes may specify frequency/duration: up to

Ability to sit for prolonged periods of time. No x Yes Daily for 60 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

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:

Senior IC

Position OverviewThe QA Engineer Digital Technologies is responsible for partnering in the Quality oversight of IT and Automation (OT) systems and provides oversight of validation program execution for these systems. This role collaborates within the Digital Technologies (DT) Quality team as well as...