CQV Engineer

Katalyst HealthCares and Life Sciences

• $90K — $120K *
Los Angeles, CA 90011In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering, Life Sciences, or related field
  • 3+ years of validation experience in a regulated industry (pharma or biotech)
  • Experience qualifying cleanroom facilities and large-scale manufacturing equipment
  • Direct production-scale experience with centrifuges and filter presses
  • Strong understanding and ability to interpret P&IDs in the field
  • Proficient in writing validation protocols and final reports
  • Experience in active construction and classified cleanroom settings
  • Full-time availability on-site in Los Angeles, CA, with flexible shifts on short notice

Responsibilities

  • Lead qualification of cleanroom facilities and large-scale manufacturing equipment
  • Author, execute, and finalize validation protocols and reports independently
  • Conduct construction walks and troubleshoot field and design issues
  • Review and approve protocols, SOPs, and vendor submittals for compliance
  • Manage project planning, scheduling, and coordination across teams using multiple software tools

Benefits

  • On-site full-time position in a dynamic and regulated industry
  • Opportunity to work on large-scale manufacturing projects
  • Exposure to a wide range of technologies and processes
  • Collaborative work environment with cross-functional teams
  • Potential for career advancement in a growing field
Full Job Description
Roles & Responsibilities:
  • Lead qualification of cleanroom facilities and large-scale manufacturing process equipment, including centrifuges and filter presses
  • uthor, 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 DeltaV, Kneat, Veeva, Bluebeam, and MS365
Education & Experience:
  • 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
* Ladders Estimates

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