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 and
- 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 and
- 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
- Candidates 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 Citizens and Green Card Holders.
