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.