Computer Systems Validation Engineer

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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.

Responsibilities:

• 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.

Requirements:

• 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.

All your information will be kept confidential according to EEO guidelines.