6493 - Lab CSV Engineer / Senior CSV Engineer

Senior Validation Engineer Responsibilities:

• Lead and execute computer system validation and equipment qualification activities for laboratory equipment integrated with LabVantage LIMS in a GxP-regulated environment
• Qualify and validate laboratory instruments and systems, with a primary focus on Climet environmental monitoring instruments and similar laboratory equipment that interface with LabVantage
• Execute vendor-provided qualification documentation and protocols, including SAT, IQ, OQ, and related testing, ensuring activities are performed in accordance with approved procedures and protocols
• Support the execution and documentation of qualification activities for laboratory instruments, primarily using existing approved protocols and documentation with minor updates to reflect equipment-specific differences
• Leverage existing approved validation and qualification documentation to efficiently develop or update URS, risk assessments, IQ/OQ documentation, test scripts, traceability, and validation summary documentation for equipment that is substantially equivalent to existing qualified units
• Evaluate existing equipment qualification and validation packages to identify required updates based on instrument configuration, LIMS integration, software, hardware, or other equipment-specific differences
• Perform and document testing of LIMS interfaces and data flows associated with laboratory instruments, ensuring accurate, complete, and reliable transfer of data between equipment and LabVantage
• Review vendor documentation and protocols for completeness and applicability and identify any gaps or deviations requiring resolution prior to or during execution
• Execute validation and qualification activities in accordance with GxP, data integrity, 21 CFR Part 11, company validation procedures, and applicable CSV/CSA principles
• Document test results, deviations, discrepancies, and exceptions and support resolution through appropriate investigation, change control, and CAPA processes
• Collaborate with Laboratory, Quality, IT, Validation, equipment vendors, and system owners to coordinate qualification activities and resolve technical or documentation issues
• Support validation documentation closeout, ensuring qualification packages are complete, accurate, traceable, and audit-ready
• Provide technical support for the laboratory equipment and LabVantage environment following qualification, including troubleshooting and assessment of changes impacting the validated state

Job Requirements:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Information Systems, or related technical discipline
• 5+ years of CSV, equipment qualification, or validation experience in a regulated life sciences environment
• 2–3+ years of experience qualifying laboratory equipment integrated with a LIMS, with hands-on LabVantage LIMS experience strongly preferred
• Demonstrated experience executing vendor-provided qualification protocols, including SAT and IQ/OQ, and accurately documenting test results, deviations, and exceptions
• Experience developing, reviewing, and executing validation and qualification documentation, including URS, risk assessments, IQ/OQ, test scripts, traceability, deviations, and validation summary reports
• Ability to leverage existing approved qualification and validation packages and efficiently adapt documentation for equivalent or similar laboratory equipment with minimal configuration differences
• Strong understanding of GxP, CSV/CSA, data integrity, 21 CFR Part 11, change control, and validation lifecycle requirements, including testing of LIMS interfaces and data flows
• Strong attention to detail, organization, troubleshooting, and communication skills, with the ability to manage a high-volume validation backlog and collaborate effectively with Laboratory, Quality, IT, Validation, and equipment vendors