Trinity Consultants - Advent Engineering · 6 hours ago
CQV Engineer
LA Metro Area
Full-time
Onsite
Senior Level
5+ years expTrinity Consultants - Advent Engineering is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. They are seeking experienced CQV Engineers to support a large-scale biotech/pharma capital project, focusing on the qualification of cleanroom facilities and manufacturing-scale process equipment in a GMP environment.
ConsultingInformation TechnologyLegal
Hiring Manager
Ana Bonilla
Responsibilities
Perform construction walk-downs to verify equipment status and conduct pre-checks against P&IDs
Draft and execute: Qualification protocols, Design documents, SOPs
Review and approve: Turnover Packages (TOPs), Vendor submittals against project specifications
Communicate and escalate technical or schedule issues as needed
Maintain and update: Project schedules, Trackers and documentation logs
Work within electronic documentation systems including: DeltaV, KNEAT, Veeva, Bluebeam, MS365 (Excel, Word, PowerPoint)
Qualification
Required
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
Proven experience qualifying: Cleanroom facilities
Proven experience qualifying: 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
Perform construction walk-downs to verify equipment status and conduct pre-checks against P&IDs
Draft and execute: Qualification protocols, Design documents, SOPs
Review and approve: Turnover Packages (TOPs), Vendor submittals against project specifications
Communicate and escalate technical or schedule issues as needed
Maintain and update: Project schedules, Trackers and documentation logs
Work within electronic documentation systems including: DeltaV, KNEAT, Veeva, Bluebeam, MS365 (Excel, Word, PowerPoint)
Company
Trinity Consultants - Advent Engineering
ADVENT provides a wide array of services supporting the entire phase of the product lifecycle - from conceptual design through production.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Ravi Baliga
CEO
Liz Wilson-SHRM CP
HR Business Partner, Life Sciences
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