CQV Engineer

Roles & Responsibilities:

• Lead qualification of cleanroom facilities and large-scale manufacturing process equipment, including centrifuges and filter presses
• Author, execute, and close validation protocols and final reports with minimal oversight
• Conduct construction walks, pre-check P&IDs, and identify, communicate, and escalate field and design issues
• Review and approve protocols, SOPs, TOPs, and vendor submittals against specifications and quality standards
• Drive execution planning, scheduling, and cross-functional coordination using Delta
  
  V, Kneat, Veeva, Bluebeam, and MS365

• Bachelor's degree in engineering, Life Sciences, or a related field
• 3+ years of experience in validation within a regulated industry (e.g., pharma, biotech)
• Proven experience qualifying cleanroom facilities and manufacturing-scale process equipment
• Direct experience with centrifuges and filter presses at production scale (laboratory-only experience is not sufficient)
• Strong understanding of P&IDs and ability to interpret and verify in the field
• Demonstrated experience writing and executing validation protocols and authoring final reports
• Experience working in active construction and classified cleanroom environments
• Must be willing to be on-site, full-time in Los Angeles, CA
• Must be able (with 3-5 days' notice) to work any shift