Validation Engineer Lead
validationengineeringgroup
Full time
Computer System Validation
About this role
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
Qualifications
Additional Information
Positions available for Puerto Rico.
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.
Frequently Asked Questions
Is the salary disclosed for the Computer System Validation position at validationengineeringgroup?
The salary for this Computer System Validation role at validationengineeringgroup is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Computer System Validation position at validationengineeringgroup located?
This Computer System Validation role at validationengineeringgroup is based in Manati, Manati, PR, Puerto Rico, PR, pr. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Computer System Validation role at validationengineeringgroup full-time or part-time?
This is listed as a Full time position. It is posted as a Computer System Validation role at validationengineeringgroup.
How do I apply for the Computer System Validation position at validationengineeringgroup?
Click the "Apply Now" button on this page. You will be redirected to validationengineeringgroup's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Computer System Validation job at validationengineeringgroup posted?
This Computer System Validation position at validationengineeringgroup was posted on Oct 6, 2020. Apply as soon as possible — early applications are often reviewed first.
Computer System Validation
validationengineeringgroup
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