CQV Engineer
2 weeks ago
ADVENT Engineering is seeking a highly skilled CQV Engineer to join our team in Albany. As a CQV Engineer, you will be responsible for executing IC/OC commissioning protocols for fermenters and the CIP skid, troubleshooting and resolving all 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
- Generate required subsequent reports
- 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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