CQV Engineer

17 hours ago

Greater Toronto Area, Canada Trinity Consultants - Advent Engineering Full time
CQV Engineer Job Description

ADVENT Engineering is seeking a highly skilled CQV Engineer to join our team in Albany, NY. As a CQV Engineer, you will be responsible for executing IC/OC commissioning protocols for fermenters and the CIP skid, troubleshooting and resolving commissioning issues, and generating commissioning summary reports.

Key Responsibilities:
  • Execute IC/OC commissioning protocols for fermenters and the CIP skid
  • Troubleshoot and resolve all commissioning issues
  • Generate commissioning summary reports
  • Generate qualification protocols for fermenters and CIP skids
  • Execute IQ/OQ qualification protocols
  • Troubleshoot and resolve all qualification issues
  • Generate qualification summary reports
  • Assist in generating CIP and SIP cycle development protocols
  • Execute CIP and SIP cycle development protocols
  • Resolve all issues encountered
  • Generate required subsequent reports
  • Assist in generating PQ protocols
  • Execute PQ protocols
  • Resolve all issues encountered and generate required subsequent reports
Requirements:
  • Bachelor's or master's degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical, or Biochemical Engineering)
  • 2-10 years of experience in the biotech-pharmaceutical academic or industrial environment
  • Basic knowledge of fermenters and unit-operations of fermenters
  • Basic knowledge of cycle development for CIP and SIP
  • Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations
  • Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc.
  • Basic knowledge of Commissioning and Qualification
  • Basic knowledge of using a Kaye validator

Candidates please note: Kindly ONLY apply if you meet the experience expectations described. 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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