Job Description

• We're seeking an experienced Computer Systems Validation (CSV) professional to join our team and lead end-to-end validation activities supporting laboratory system upgrades and data integrity initiatives. This role is ideal for someone with a strong background in regulated environments and hands-on experience with modern lab software and instrumentation.
• This is a short-term contract assignment running through September and requires individuals to work onsite.

• Lead and execute full-cycle CSV processes across multiple systems, ensuring compliance with regulatory standards.
• Spearhead system upgrade projects, including migration from Windows 10 to Windows 11.
• Validate laboratory software and equipment including LabX, UV-Vis spectroscopy, and FTIR software systems.
• Collaborate with cross-functional teams on the integration of data systems and implementation of audit trails, access controls, and data integrity strategies.
• Provide guidance and training to internal stakeholders on CSV protocols and lab systems.
• Document validation activities and maintain accurate records for audits and inspections.

• 5 10 years of hands-on experience in Computer Systems Validation, preferably in regulated industries such as pharma, biotech, or medical devices.
• Demonstrated ability to perform software upgrades and oversee validation.
• Extensive hands-on experience with LabX, UV-Vis spectroscopy, and FTIR software systems.
• Proven ability to write, develop, and execute validation protocols.
• Proven end-to-end CSV experience, including planning, execution, documentation, and remediation.
• Strong working knowledge of laboratory equipment software, with hands-on lab experience being a strong plus.
• Familiarity with data integration frameworks and regulatory requirements around audit trails and access control.

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