- Piscataway, New Jersey, United States
- Senior
- 8+ years
Lead Computer System Validation activities across regulated laboratory, engineering, manufacturing, and enterprise systems.
Responsibilities
- Plan, author, and execute validation deliverables (VP, URS, FS, DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports)
- Support CSV activities across lab instruments, engineering and manufacturing equipment, and enterprise systems including Caliber LIMS, SAP, and BMRAM
- Partner with system owners, QA, and IT to maintain systems in a validated state through change control and periodic review
- Execute risk assessments and data integrity assessments aligned with ALCOA+ principles
- Support audits, inspections, CAPA investigations, and deviations related to computerized systems
Requirements
- Bachelor's Degree (BA/BS) Life Sciences, Engineering, or IT, or equivalent laboratory experience in a life sciences environment