CQV Engineer

IMPORTANT:
We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered 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, process engineering, and quality system projects.

ADVENT’s 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.

• 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
• Generate qualification protocols for the fermenters & CIP skids
• Troubleshoot and resolve all qualification issues
• Generate qualification summary reports for all respective protocols
• Assist in 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 generating the required PQ protocols
• Execute the PQ protocols
• Resolve all issues encountered

• Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical, or Biochemical Engineering). 2‑10 years of experience in a biotech‑pharmaceutical academic or industrial environment.
• 5+ years of experience in CQV within a regulated biotech or pharmaceutical environment.
• Basic knowledge of fermenters and unit operations of fermenters
• Basic knowledge of cycle development for CIP and SIP
• Basic knowledge of regulatory compliance including cGMP, OSHA, EPA, and FDA regulations
• Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, SharePoint, etc., and experience working within shared work environments.
• Basic knowledge of Commissioning and Qualification processes
• 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.

Mid‑Senior level

• Full‑time

• Engineering and Consulting

• Pharmaceutical Manufacturing

• Medical insurance
• Vision insurance
• 401(k)
• Paid maternity leave