CQV Engineer

Process CQV Engineer (Biotech/Pharma)Location – Southern California Please note: 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 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.This is an outstanding opportunity to join our growing team!Position OverviewWe 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 ExperienceRequires 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 manufacturingProven experience qualifying: Cleanroom facilities Large-scale process equipment including vessels, centrifuges, and CIP skidsMust have authored and executed qualification protocols and written final reportsExperience executing CQV activities during construction and cleanroom conditionsKey ResponsibilitiesPerform construction walk-downs to verify equipment status and conduct pre-checks against P&IDsDraft and execute:Qualification protocolsDesign documentsSOPsReview and approve:Turnover Packages (TOPs)Vendor submittals against project specificationsCommunicate and escalate technical or schedule issues as neededMaintain and update:Project schedulesTrackers and documentation logsWork within electronic documentation systems including:DeltaVKNEATVeevaBluebeamMS365 (Excel, Word, PowerPoint)