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Senior QA Engineer, Validation

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 22 August 2026 (2 days ago)

Application Deadline: 19 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

The Senior QA Engineer Validation helps drive the Quality oversight for Commissioning Qualification and Validation (CQV) processes. The position also oversees reviews and approves QA validation activities and documents associated with decommissioning new or modified systems as well as maintenance of the validated state of equipment processes and systems. Occasional opportunities for international and/or domestic travel may be available for this role.

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

Serves as QA CQV subject matter expert (SME) with regulators clients and company management.
Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure facilities utilities and equipment are first validated and then maintained in a validated state.
Oversees and approves system and process lifecycle documentation including risk and impact assessments user requirements product process and equipment specifications functional specifications traceability matrices qualification protocols validation plans and validation summary reports.
Develops reviews and approves QA procedures for the validation approach and lifecycle documents for facilities utilities and equipment.
Ensures the completion of project and operational quality objectives within desired timelines.
Provides manufacturing (Clean Room) shop floor support for issue resolution as needed.
Participates in optimization or improvement initiatives.
Supports regulatory agencies and third-party inspections.
Shares knowledge and mentors less experienced team members by providing technical guidance on QA validation activities.
Performs other duties as assigned.

Knowledge Skills and Abilities

Ability to work in a highly regulated environment adhere to regulatory requirements and follow Good Manufacturing Practices (GMP).
Advanced ability to manage multiple assignments meet deadlines and balance competing priorities in a fast-paced GMP environment; excellent organization and critical thinking skills with ability to work independently.
High-level understanding of production equipment hygienic utilities quality systems automation manufacturing & IT Systems Cleaning Development/Verification/Validation and CQV methodologies.
Ability to support SOP creation program development and training curricula to deliver operational and inspection readiness goals.
Excellent communication skills both written and oral to effectively collaborate cross-function and with department management.
Extensive knowledge of Data Integrity and application of 21 CFR Part 820 and Part 11.
Personal ownership proactive partnerships and knowledge management.
Ability to fully embrace a Genki culture and bring positive energy to a dynamic work environment.
Flexible to support a 24/7 manufacturing facility.

Minimum Qualifications

Bachelors degree in Life Sciences or Engineering with 8 years of applicable industry experience; OR
Masters degree in Life Sciences or Engineering with 6 years of applicable industry experience; OR;
PhD in Life Sciences or Engineering with 4 years of applicable industry experience.
4 years of experience working in a GMP regulated environment.
Experience in Commissioning Qualification and Validation (CQV) and Quality oversight in an FDA regulated facility.

Preferred Qualifications

Working knowledge and experience with ASTM E2500 Smartsheets Trackwise Veeva and Kneat validation software.
High level of familiarity/understanding of Drug Substance Drug Product and/or Finished Goods manufacturing processes.
Experience with complex projects.
Experience with startup projects or initiatives.
Training and/or familiarity with Quality Risk Management principles.

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 120 minutes.
Ability to sit for prolonged periods of time for up to 120 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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