Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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.