6191 - Senior CQV Engineer / Senior Validation Engineer
Verista, Inc.9 months ago
Los Angeles, CA, United States
On-site
Full-time
Junior Level (1-3 years)
Job Description
Senior CQV Engineer 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 DeltaV, Kneat, Veeva, Bluebeam, and MS365
Job Qualifications:
- Bachelor's degree in engineering, Life Sciences, or a related field
- 5-10+ years of relevant 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, including holidays
Required Skills
Protocol authoring and execution
P&ID review and interpretation
Cross-functional coordination
Manufacturing process equipment validation
Veeva
Kneat
Qualification of cleanroom facilities
Construction walk reviews
MS365
DeltaV
Bluebeam