QA Engineer, Digital Technologies

FUJIFILM Electronic Materials U.S.A., Inc.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer, Digital Technologies to oversee IT and automation systems within a cGMP environment. You will partner with the DT Quality team to ensure QA governance for project deliverables and accurate validation across the system lifecycle.

The role emphasizes collaboration with global teams, strong English communication, and adherence to data integrity and regulatory requirements. On-site work with travel may be required as projects evolve.

Qualifications

• Bachelor’s in related science field with 5+ years applicable experience; OR, Master’s with 3+ years; OR, PhD with 1+ year.
• 3+ years of experience in a GMP regulated environment.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility.
• Experience with ASTM E2500, CSV/CSA, and ALCOA+.

Responsibilities

• Partner in QA oversight of IT and Automation (OT) systems from project phase to operational readiness.
• Provide QA oversight and support of project deliverables per DT program processes.
• Assess impact of system and process changes; oversee change management to keep validated state.
• Review and approve lifecycle documentation: risk/impact assessments, specs, traceability, validation plans, and validation reports.
• Generate and approve QA procedures for validation approaches and lifecycle documents.
• Generate and approve QA documentation for operational readiness and QA support of manufacturing operations.
• Ensure project and operational quality objectives meet timelines.
• Collaborate with FUJIFILM Biotechnologies sites to streamline processes.
• Support startup activities and system improvements; assist with regulatory inspections.

Skills

Collaboration

Fluent English

Quality Risk Management

Validation

cGMP knowledge

Data Integrity

GAMP5

Time management

Agile

Domestic/International travel

Education

Bachelor's degree in related science

Master's degree in related science

PhD in related science

Tools

Smartsheet

Kneat

DeltaV DCS

DeltaV MES

PAS-X

PI System

Job description

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, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll 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 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.
• Knowledge and application of cGMP compliance and other related regulations.
• 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

• Bachelor’s 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 Qualifications

• 5+ years of experience in a GMP quality assurance (QA) role with oversight of Automation GxP systems validation and lifecycle.
• Prior experience with Smartsheet and electronic validation software (e.g. Kneat).
• Previous experience with the following processes preferred: Manufacturing Automation (e.g., DeltaV DCS, DeltaV MES, PAS-X, Octoplant, VDS, ICE, PI System).
• Prior experience and understanding of Data Integrity activities (e.g., Data Integrity Assessment, Audit Trail Review).

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 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.

*LI-Onsite

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 ([e-mail]).