CQV Engineer
LVI Associates - boston, MA
Apply NowJob Description
ResponsibilitiesThe role entails the primary job functions:Execute ICOC 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 IQOQ 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 andor 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 Citizens and Green Card Holders.
Created: 2024-09-30