QA Engineer, Digital Technologies

Fujifilm - Holly Springs, NC

Full-time

Holly Springs, NC

Machinery Manufacturing

About the position

The QA Engineer, Digital Technologies at FUJIFILM Diosynth Biotechnologies is responsible for ensuring quality oversight of IT and Automation systems throughout their operational readiness. This role involves collaboration with various project teams and QA departments to maintain consistent policy administration and address any operational issues. The position plays a critical role in the validation of systems and processes, ensuring compliance with regulatory standards in a cGMP environment, and supporting the manufacturing of biopharmaceuticals.

Responsibilities

• Partner in the Quality oversight of IT and Automation (OT) systems through to operational readiness.
• Provide oversight of validation program execution for IT and Automation systems.
• Assess the impact of system and process modifications and maintain oversight of change management processes.
• Provide oversight and approval of system and process lifecycle documentation.
• Generate, review, and approve QA procedures for validation approaches and lifecycle documents.
• Ensure project and operational quality objectives are met within desired timelines.
• Collaborate with other FUJIFILM Diosynth Biotechnologies sites to streamline processes.
• Develop and support startup activities into operations as the project matures.

Requirements

• Bachelor's in related science field with 6+ years applicable experience OR Master's in related science field with 4+ years applicable experience OR PhD with 2+ years applicable experience.
• Experience in Validation, cGMP manufacturing operations and/or Quality oversight in an FDA regulated facility.
• Working knowledge of ASTM E2500, CSV/CSA, and ALCOA+.
• Understanding of GAMP5, Data Integrity, and application of 21 CFR Part 820 and Part 11/Annex 11.

Nice-to-haves

• A minimum of 4-6 years 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 IT and/or OT related infrastructure and QC IT Systems (e.g. Empower, SoloVPE, PLA, LIMS, LabX).