CQV Engineer

Responsibilities

The role entails the primary job functions:

• Execute IC/OC commissioning protocols for fermenters and the CIP skid
• Troubleshoot and resolve all commissioning issues
• Generate 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 issues
• Generate the qualification summary reports for all respective protocols.
• Assist or generate the CIP and SIP cycle development protocols
• Execute the CIP and SIP cycle development protocols.
• Resolve all issues encountered
• Generate the required subsequent reports.
• Assist in the generation of the required PQ protocols
• Execute the PQ protocols.
• Resolve all issues encountered
• Generate the required subsequent reports

Qualifications

• Requires 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 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. in addition to experience working within shared work environments.
• Basic knowledge of the Commissioning and Qualification.
• Basic knowledge of using a Kaye validator

Note to Candidates: 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 Citizens and Green Card Holders.