CQV Engineer

5 days ago

Greater Toronto Area, Canada Trinity Consultants - Advent Engineering Full time

CQV Engineer (Biotech)Location – AlbanyAre you a Canadian Citizen who wants to work in the US for a 6-month contract in Albany, NY?ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.This is an outstanding opportunity to join our growing teamResponsibilitiesThe role entails the primary job functions:Execute IC/OC commissioning protocols for fermenters and the CIP skidTroubleshoot and resolve all commissioning issuesGenerate the commissioning summary reports for all respective protocols.Generation of the qualification protocols for the fermenters & CIP skids.Execute IQ/OQ qualification protocols.Troubleshoot and resolve all qualification issuesGenerate the qualification summary reports for all respective protocols.Assist or generate the CIP and SIP cycle development protocols andExecute the CIP and SIP cycle development protocols.Resolve all issues encounteredGenerate the required subsequent reports.Assist in the generation of the required PQ protocolsExecute the PQ protocols.Resolve all issues encountered andGenerate the required subsequent reportsQualificationsRequires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering) degree. 2-10 years of experience in the biotech-pharmaceutical academic or industrial environment.Basic knowledge of fermenters and unit-operations of fermentersBasic knowledge of cycle development for CIP and SIPBasic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations.Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.Basic knowledge of the Commissioning and Qualification.Basic knowledge of using a Kaye validatorCandidates please note: Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Interested candidates with direct related experience in US or Toronto locations are encouraged to apply. Accepting US/Canadian Citizens and Green Card Holders.

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    13 hours ago

    Greater Toronto Area, Canada Trinity Consultants - Advent Engineering Full time

    Career OpportunityWe are seeking a highly skilled Senior CQV Specialist to join our team at Trinity Consultants - Advent Engineering. This role involves working with engineers to execute IC/OC commissioning protocols, generate reports, and troubleshoot issues.Responsibilities and QualificationsKey responsibilities for this position include executing IC/OC...

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    5 days ago

    Greater Toronto Area, Canada Trinity Consultants - Advent Engineering Full time

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    5 days ago

    Greater Toronto Area, Canada Trinity Consultants - Advent Engineering Full time

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