{"schemaVersion":"jobsearcher.job.v1","id":"b6d9ae51ec0a52b4849831e6","url":"https://jobsearcher.com/jobs/b6d9ae51ec0a52b4849831e6","canonicalUrl":"https://jobsearcher.com/jobs/b6d9ae51ec0a52b4849831e6","title":"Computer System Validation","description":"Company Description\n\nValidation & Engineering Group, Inc is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA.\n\nJob Description\n\n• URS development, routing for approval and DCA process • DCA Management (Request doc numbers, upload, approval and route for approval) • Systems\nImpact Assessment. Be advice that Engineering impact assessment and CSV impact\nassessment are two different forms. • Maximo CMMS o Data Entry into Maximo CMMS o Spare Parts(must include all necessary parts such as but not limited\nto: instruments temperature/humidity, calibration form, chart recorder, fuses, relays, breakers, boards etc) o Job Plan/PM (Electrical & Mechanical) o Equipment\n& Instrument Forms o Job Plan Trainings • Commissioning protocol development, routing for approval, execution and DCA process • Include a characterization\ntest as part of the commissioning • Commissioning protocol report development, routing for approval and DCA process • Risk assessment development,\nrouting for approval and DCA process • Validation Plan development/routing for approval and DCA process • IOQ protocol development, execution routing for\nreview/approval. Including associated completion forms per each stage(IQ, OQ) as per V-S-001 • Contractor must install data loggers for temperature and\nhumidity mapping • Contractor must download recorded data from data loggers to confirm that the test is in compliance with protocol requirements • Up to 3\ndocument revisions must be included( 3 offline revision, 3 approval process revision) • Initial and final Traceability matrix development, execution, approval and\nDCA process. • TM Report • VP Report • IOQ Report • Data mapping & Data flow protocol development routing for approval and associated report as\napplicable including DCA management • Removal of existing control panel spare parts from CMMS system. • TOP: Turn Over Package development,\nexecution and completion. • SOP’S: one administrative SOP and one Operational SOP • CSV/IT job plan review to include yearly backup generation • Change\ncontrol management: development, presentation for endorsement, change action documentation and change control closing • QBAS & BAS scope: this\nchamber has temperature and humidity signals that are reported to QBAS/BAS system as part of the scope contractor must: o Format and upload to DCA:\nSAT, DS associated to BAS o Execute SAT with Honeywell o Develop SAT report including associated form o DCA management for SAT protocol & report\n\nAdditional Information\n\nPositions available for Puerto Rico.\nValidation and Engineering Group, Inc is an Equal Employment Opportunity employer.","company":"Validation","rawCompany":"validation","city":"Manati","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-05-23T08:50:33.146Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation","description":"Company Description\n\nValidation & Engineering Group, Inc is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA.\n\nJob Description\n\n• URS development, routing for approval and DCA process • DCA Management (Request doc numbers, upload, approval and route for approval) • Systems\nImpact Assessment. Be advice that Engineering impact assessment and CSV impact\nassessment are two different forms. • Maximo CMMS o Data Entry into Maximo CMMS o Spare Parts(must include all necessary parts such as but not limited\nto: instruments temperature/humidity, calibration form, chart recorder, fuses, relays, breakers, boards etc) o Job Plan/PM (Electrical & Mechanical) o Equipment\n& Instrument Forms o Job Plan Trainings • Commissioning protocol development, routing for approval, execution and DCA process • Include a characterization\ntest as part of the commissioning • Commissioning protocol report development, routing for approval and DCA process • Risk assessment development,\nrouting for approval and DCA process • Validation Plan development/routing for approval and DCA process • IOQ protocol development, execution routing for\nreview/approval. Including associated completion forms per each stage(IQ, OQ) as per V-S-001 • Contractor must install data loggers for temperature and\nhumidity mapping • Contractor must download recorded data from data loggers to confirm that the test is in compliance with protocol requirements • Up to 3\ndocument revisions must be included( 3 offline revision, 3 approval process revision) • Initial and final Traceability matrix development, execution, approval and\nDCA process. • TM Report • VP Report • IOQ Report • Data mapping & Data flow protocol development routing for approval and associated report as\napplicable including DCA management • Removal of existing control panel spare parts from CMMS system. • TOP: Turn Over Package development,\nexecution and completion. • SOP’S: one administrative SOP and one Operational SOP • CSV/IT job plan review to include yearly backup generation • Change\ncontrol management: development, presentation for endorsement, change action documentation and change control closing • QBAS & BAS scope: this\nchamber has temperature and humidity signals that are reported to QBAS/BAS system as part of the scope contractor must: o Format and upload to DCA:\nSAT, DS associated to BAS o Execute SAT with Honeywell o Develop SAT report including associated form o DCA management for SAT protocol & report\n\nAdditional Information\n\nPositions available for Puerto Rico.\nValidation and Engineering Group, Inc is an Equal Employment Opportunity employer.","datePosted":"2026-05-23T08:50:33.146Z","dateModified":"2026-05-23T08:50:33.146Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Manati","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b6d9ae51ec0a52b4849831e6"},"url":"https://jobsearcher.com/jobs/b6d9ae51ec0a52b4849831e6"}}