Senior Quality Assurance Validation Specialist
Core
Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support manufacturing standards for life-changing medicines.
Role type
Senior Quality Assurance Validation Specialist
Builds
Validated equipment, systems, and processes for pharmaceutical manufacturing
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Validation protocol generation and execution, deviation investigation, change control review, cleanroom gowning procedures, temperature mapping, vibration and shock profile analysis, humidity and pressure sensor programming, ASTM/ISTA standards application, small-parcel and palletized-load qualification
Preferred skills
None stated
Technologies
None stated
Responsibilities
Generate, execute, and review validation protocols and reports; Analyze testing results against acceptance criteria; Investigate and troubleshoot problems; Review and approve deviation notifications and corrective actions; Coordinate with departments or contractors to complete validation tasks; Conduct temperature mapping for controlled environments; Program instrumentation for vibration, shock, humidity, and pressure data capture; Apply ASTM and ISTA standards to cold-chain shipping design and testing.
Seniority
Senior, hands-on IC
