Principal Quality Assurance Validation Specialist
$92.2k - $176kRegeneron Pharmaceuticals, Inc.
Regeneron seeks a Principal Quality Assurance Validation Specialist to validate and qualify laboratory and analytical equipment at a new automated biologics manufacturing facility in Saratoga Springs. The role involves protocol development, testing analysis, troubleshooting, and potential team leadership in a regulated environment.
Responsibilities
- Generate, execute, and review qualification and validation protocols, reports, and data for laboratory equipment
- Analyze test results and determine acceptability against predetermined acceptance criteria
- Investigate equipment problems and recommend solutions or process improvements
- Review and approve deviation notifications, investigations, corrective actions, and documentation
- Train, mentor, and potentially manage full-time employees and contractors
Requirements
- Bachelor's degree in Engineering, Chemistry, or Life Sciences, or equivalent relevant experience
- 8+ years of quality assurance validation or related experience
- Experience with laboratory instrumentation (HPLC, GC, balances, spectrophotometers) in GMP environments preferred
- Previous people leadership or supervisory experience preferred
- Ability to work in cleanroom environment with full gowning requirements
- Capability to coordinate across quality, manufacturing, and vendor teams
Compensation: $92,200-$176,000 annually
Vacancy posted 10 days ago
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