CQV Engineer

2 months ago

Boston, United States LVI Associates Full time

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.

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