QA Engineer, Digital Technologies — Validation & Quality Oversight
HireLifeScience
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Job summary
Fujifilm Biotechnologies in Holly Springs, NC seeks a QA Engineer, Digital Technologies to oversee IT and OT system validation and QA processes, ensuring compliance and operational readiness. The role collaborates with the DT Quality team and site QA to manage lifecycle documentation, risk assessment, and regulatory readiness.
The candidate will coordinate validation activities, support start-up operations, and prepare for inspections while maintaining a validated state from startup through
Qualifications
- Bachelor's in related science field; 5+ years in GMP/QA environment.
- Masters in related science with 3+ years experience; PhD with 1+ year.
- Experience with validation, cGMP manufacturing operations, and QA oversight in FDA-regulated settings.
- Familiarity with ASTM E2500, CSV/CSA, and ALCOA+.
Responsibilities
- Provide QA oversight of IT and OT systems throughout project phases to ensure validated state.
- Approve lifecycle documentation including risk assessments, specs, protocols, and validation reports.
- Develop and approve QA documentation, processes, and procedures for program compliance and operations.
- Support regulatory inspections and align with multi-site QA practices to improve efficiency.
Skills
Education
Tools
Job description
Fujifilm Biotechnologies in Holly Springs, NC seeks a QA Engineer, Digital Technologies to oversee IT and OT system validation and QA processes, ensuring compliance and operational readiness. The role collaborates with the DT Quality team and site QA to manage lifecycle documentation, risk assessment, and regulatory readiness.
The candidate will coordinate validation activities, support start-up operations, and prepare for inspections while maintaining a validated state from startup through
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