QA Engineer, Digital Tech - IT/OT Validation & Oversight

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

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.