CQV Engineer

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 and 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. Position Overview We are seeking experienced CQV Engineers to support a large-scale biotech/pharma capital project in Southern California. The role will focus on qualification of cleanroom facilities and manufacturing‑scale process equipment in an active construction and GMP environment. Required Experience Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering) degree. 5–10 years of CQV experience in biotech or pharmaceutical manufacturing Cleanroom facilities Large‑scale process equipment including vessels, centrifuges, and CIP skids Must have authored and executed qualification protocols and written final reports. Experience executing CQV activities during construction and cleanroom conditions. Key Responsibilities Perform construction walk‑downs to verify equipment status and conduct pre‑checks against P&IDs Draft and execute: Qualification protocols SOPs Review and approve: Turnover Packages (TOPs) Vendor submittals against project specifications Communicate and elevate technical or schedule issues as needed. Maintain and update: Trackers and documentation logs Work within electronic documentation systems including: #J-18808-Ljbffr Trinity Consultants - Advent Engineering