Computer System Validation

Company Description Validation & 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. Job Description • URS development, routing for approval and DCA process • DCA Management (Request doc numbers, upload, approval and route for approval) • Systems Impact Assessment. Be advice that Engineering impact assessment and CSV impact assessment 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 to: instruments temperature/humidity, calibration form, chart recorder, fuses, relays, breakers, boards etc) o Job Plan/PM (Electrical & Mechanical) o Equipment & Instrument Forms o Job Plan Trainings • Commissioning protocol development, routing for approval, execution and DCA process • Include a characterization test as part of the commissioning • Commissioning protocol report development, routing for approval and DCA process • Risk assessment development, routing for approval and DCA process • Validation Plan development/routing for approval and DCA process • IOQ protocol development, execution routing for review/approval. Including associated completion forms per each stage(IQ, OQ) as per V-S-001 • Contractor must install data loggers for temperature and humidity mapping • Contractor must download recorded data from data loggers to confirm that the test is in compliance with protocol requirements • Up to 3 document revisions must be included( 3 offline revision, 3 approval process revision) • Initial and final Traceability matrix development, execution, approval and DCA process. • TM Report • VP Report • IOQ Report • Data mapping & Data flow protocol development routing for approval and associated report as applicable including DCA management • Removal of existing control panel spare parts from CMMS system. • TOP: Turn Over Package development, execution and completion. • SOP’S: one administrative SOP and one Operational SOP • CSV/IT job plan review to include yearly backup generation • Change control management: development, presentation for endorsement, change action documentation and change control closing • QBAS & BAS scope: this chamber 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: SAT, DS associated to BAS o Execute SAT with Honeywell o Develop SAT report including associated form o DCA management for SAT protocol & report Additional Information Positions available for Puerto Rico. Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.