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The Commissioning,Qualification and Validation (CQV) Engineer will provide CQV services toclients in the Life Sciences Industry. The position provides an excellentopportunity to work for a Global Engineering Firm and support clients thatmanufacture life changing products. This position shall be responsible for the developmentand execution of CQV documentation on a variety of equipment, facilities,utilities, components, products, and systems for a diverse client base ofbiotechnology, pharmaceutical, medical device, gene therapy and cell therapymanufacturers.
ProvideCQV support to clients that manufacture GMP products on a consistent basis inconjunction with industry best practices:
DevelopCQV planning documents to manage CQV projects
Generateand execute CQV protocols using Good Documentation Practices (GDPs)
Investigateand resolve protocol exceptions or discrepancies
Developtechnical reports and CQV summary reports
Startupequipment in a safe and effective manner
Readand verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.)
DevelopStandard Operating Procedures (SOPs), process workflows, Validation MasterPlans, User Requirement Specifications, Turnover Packages, and other regulatorysupport documentation
Performrisk assessments and impact assessments
Applyengineering knowledge of, and experience with, manufacturing equipment, processequipment, HVAC, utilities, instrumentation, controls, and automation to supportclients
Theideal candidate for this position will possess the following:
Abilityto use test and measurement equipment (e.g., KAYE Validators)
Knowledgeof US FDA (21 CFR phone number removed> ) and EU EMEA regulations
Knowledgeof industry guidance:
ISPEBaseline Guide 5 Commissioning and Qualification
ISPEGAMP V, A Risk Based Approach to Compliant GMP Computerized Systems
ASTME2500 Standard Guide for Specification, Design, and Verification ofPharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ISPEGuideline: Science and Risk-based Approach for the Delivery of Facilities,Systems, and Equipment, 2011
ISPEGood Practice Guide: Applied Risk Management for Commissioning andQualification, 2011
Candidatesmust have unrestricted rights to work in the U.S.
Jacobs leads the global professional services sector delivering solutions for a more connected, sustainable world.
With $15.0 billion in combined revenue and a talent force more than 77,000 strong, Jacobs provides a full spectrum of services including scientific, technical, professional, construction- and program-management for business, industrial, commercial, government and infrastructure sectors.
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