Job Description
Job Description
One of our large biopharmaceutical clients is seeking a CSV specialist to join their team for a Windows 11 upgrade. This role focuses on assessing system impact, executing validation deliverables, coordinating with the DeltaV and MES team to ensuring that all upgraded platforms meet regulatory, data integrity, and business continuity requirements. The ideal candidate brings deep experience in Computer System Validation (CSV) within a regulated biopharmaceutical environment and is comfortable working at the intersection of IT infrastructure and GMP operations.
Key Responsibilities
Work on CSV activities related to the Windows 11 operating system upgrade across GxP‑impacted systems and applications.
Perform system impact assessments, risk evaluations, and gap analyses to determine validation scope.
Develop and execute validation documentation, including URS, FRS, RTM, IQ/OQ/PQ, and validation summary reports.
Partner with IT, Qua...
One of our large biopharmaceutical clients is seeking a CSV specialist to join their team for a Windows 11 upgrade. This role focuses on assessing system impact, executing validation deliverables, coordinating with the DeltaV and MES team to ensuring that all upgraded platforms meet regulatory, data integrity, and business continuity requirements. The ideal candidate brings deep experience in Computer System Validation (CSV) within a regulated biopharmaceutical environment and is comfortable working at the intersection of IT infrastructure and GMP operations.
Key Responsibilities
Work on CSV activities related to the Windows 11 operating system upgrade across GxP‑impacted systems and applications.
Perform system impact assessments, risk evaluations, and gap analyses to determine validation scope.
Develop and execute validation documentation, including URS, FRS, RTM, IQ/OQ/PQ, and validation summary reports.
Partner with IT, Qua...
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