CBS Butler Recruitment · 4 days ago
Senior Validation Engineer
Irvine, CA
Full-time
Onsite
Senior Level
$110K/yr - $130K/yr
7+ years expCBS Butler Recruitment is seeking an experienced Senior Validation Engineer to lead validation activities in a state-of-the-art sterile injectable and biopharmaceutical facility. The role focuses on ensuring compliance and validation of equipment, utilities, and systems while supporting high-quality manufacturing.
Staffing & Recruiting
Hiring Manager
Luke G
Responsibilities
Lead all aseptic filling lines, isolators/RABS, cleanrooms, critical utilities, and computerized systems
Plan and maintain Validation Master Plans (VMPs) and related documentation
Perform process and cleaning validations, including media fills
Validate critical utilities like WFI, clean steam, HVAC, and compressed gases
Drive investigations, deviations, CAPAs, change controls, and risk assessments
Qualification
Required
Bachelor's degree in Engineering or Life Sciences
7+ years of hands-on validation experience in sterile injectable or biopharmaceutical manufacturing
Strong knowledge of FDA cGMPs, EU GMP Annex 1, and global regulatory requirements
Excellent technical writing and documentation skills
Company
CBS Butler Recruitment
501-1000 employeesFunding
Current Stage
Late StageCompany data provided by crunchbase