CQV Engineer (Biotech)
This company is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
This clients services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.
This is an outstanding opportunity to join our growing team!
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
- 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