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Senior Engineer, QA Digital Technologies

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 5 August 2026 (30+ days ago)

Application Deadline: 9 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

The Senior Engineer QA 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.
Independently provides QA oversight subject matter expertise and support of project deliverables in accordance with governing processes and procedures for the Digital Technologies 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 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.

Knowledge Skills and Abilities

Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Excellent oral and written communications skills and fluency in English.
Training and/or familiarity with Quality Risk Management principles.
Familiarity/understanding of validation of production equipment hygienic utilities quality systems automation manufacturing & IT Systems and methodologies.
Strong time management ability to meet tight deadlines to ensure effective prioritization of tasks.
Ability to be agile and flexible to meet internal and external needs.
Understanding of GAMP5 Data Integrity and application of 21 CFR Part 820 and Part 11/Annex 11.
Occasional opportunity for International and/or Domestic travel may be available.

Minimum Qualifications

Bachelors degree and 8 years applicable experience; OR
Masters degree and 6 years applicable experience; OR
PhD and 4 years applicable experience.
4 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 Qualifications

Prior experience with Smartsheet and electronic validation software (e.g. Kneat).
Understanding of one or more of the following processes preferred:
- GxP systems
- Serialization
- Infrastructure (IT and/or OT related)
- Manufacturing Execution Systems (MES)
- Process Control Systems (PCS) and Building Management Systems (BMS)
- PI Historian

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job the employee is required on a regular basis to:

Ability to discern audible cues.
Ability to stand for prolonged periods of time for up to 60 minutes.
Ability to sit for prolonged periods of time for up to 60 minutes.
Ability to conduct activities using repetitive motions that include wrists hands and/or fingers.
Ability to conduct work that includes moving objects up to 10 pounds.

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

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About Company

Fujifilm

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