QA Engineer, Digital Technologies

Fujifilm - Holly Springs, NC

Full-time

Holly Springs, NC

Machinery Manufacturing

About the position

The QA Engineer, Digital Technologies is responsible for ensuring quality oversight of IT and Automation systems throughout their operational readiness. This role involves collaborating with the Digital Technologies Quality team and other project teams to maintain consistent policy administration and provide QA oversight of daily activities. The engineer will also oversee validation program execution and ensure compliance with quality objectives in a cGMP regulated environment.

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, including risk assessments and validation plans.
• 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 a Master's in related science field with 4+ years applicable experience OR a 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).