Computer Systems Validation EngineerKatalyst HealthCares & Life Sciences • Bethlehem, PA
Computer Systems Validation Engineer
Katalyst HealthCares & Life Sciences • Bethlehem, PA
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job_description.job_card.job_descriptionLead 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. – 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.
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 :
Requirements :
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Validation Engineer • Bethlehem, PA
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