Trinity Consultants - Advent Engineering
CQV Engineer
Trinity Consultants - Advent Engineering, Los Angeles, California, United States, 90079
Process CQV Engineer (Biotech/Pharma)
Location
– Southern California
Employment type
– Full‑time, Mid‑Senior level
W2 only
– 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, we are 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.
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
Bachelor’s or Master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering).
5–10 years of CQV experience in biotech or pharmaceutical manufacturing.
Experience with cleanroom facilities and large‑scale process equipment (vessels, centrifuges, CIP skids).
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&ID.
Draft and execute qualification protocols and SOPs.
Review and approve Turnover Packages (TOPs) and vendor submittals against project specifications.
Communicate and escalate technical or schedule issues as needed.
Maintain and update trackers and documentation logs.
Work within electronic documentation systems including KNEAT, Veeva, and MS365 (Excel, Word, PowerPoint).
#J-18808-Ljbffr
– Southern California
Employment type
– Full‑time, Mid‑Senior level
W2 only
– 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, we are 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.
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
Bachelor’s or Master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering).
5–10 years of CQV experience in biotech or pharmaceutical manufacturing.
Experience with cleanroom facilities and large‑scale process equipment (vessels, centrifuges, CIP skids).
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&ID.
Draft and execute qualification protocols and SOPs.
Review and approve Turnover Packages (TOPs) and vendor submittals against project specifications.
Communicate and escalate technical or schedule issues as needed.
Maintain and update trackers and documentation logs.
Work within electronic documentation systems including KNEAT, Veeva, and MS365 (Excel, Word, PowerPoint).
#J-18808-Ljbffr