CSV Specialist

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 IT and Quality, and 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., 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, Quality Assurance, and system owners to ensure compliant implementation and smooth transition of validated systems.

Review vendor documentation and assess suitability for GMP use.

Ensure all changes follow change control, deviation management, and data integrity requirements.

Support testing activities, including regression testing, functional verification, and system compatibility checks.

Maintain clear documentation and traceability throughout the validation lifecycle.

Provide guidance on regulatory expectations related to OS upgrades, cybersecurity, and system lifecycle management.

Support audits and inspections by providing validation evidence and subject-matter expertise.

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Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.

3-7+ years of experience in a GMP biopharmaceutical, biotech, or pharmaceutical environment. Kneat experience

Experience with CSV or Validation