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Computer Systems Validation Engineer

Computer Systems Validation Engineer

Katalyst HealthCares & Life SciencesBethlehem, PA
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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 to Windows .
  • 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 :

  • 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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    Validation Engineer • Bethlehem, PA