Senior Quality Assurance Validation Specialist
Core
Validate and qualify equipment, systems, and processes in a manufacturing environment to ensure compliance with regulatory requirements and company standards.
Role type
Senior Quality Assurance Validation Specialist
Builds
Validated manufacturing equipment, systems, and processes
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation protocol generation and execution, deviation investigation, change control management, 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
Experience with cold-chain shipping design and testing
Technologies
IPA, ASTM standards, ISTA standards
Responsibilities
Generate and execute validation protocols and summary reports; analyze testing results against acceptance criteria; investigate and troubleshoot problems; approve deviation notifications and corrective actions; review and approve change controls and SOPs; coordinate with departments and contractors for validation tasks; conduct temperature mapping; program instrumentation for vibration/shock/humidity/pressure analysis; perform packaging qualifications.
Seniority
Senior, hands-on IC
