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 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.
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, 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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Required Skills & Experience
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.
Nice to Have Skills & Experience
Kneat experience
Experience with CSV or Validation
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.