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Entry LevelFull-time
Salary Range
$51,000 - $69,000 /year
This salary is estimated based on similar roles. The actual salary may vary.
Key Responsibilities
- →Lead and execute qualification activities for facility utilities and equipment including temperature-controlled chambers, water for injection, clean steam, process tanks, and autoclaves
- →Support Factory Acceptance Testing in conjunction with Project Engineer
- →Identify risk controls, critical elements and traceability of equipment design
- →Develop, review, and approve validation protocols such as URS, FRS, DQ, IQ, OQ, PQ protocols as well as summary reports
- →Lead and document troubleshooting efforts of issues encountered during commissioning and qualification
- →Ensure risk-based validation approaches following current industry guidelines
- →Support projects ensuring validation requirements are integrated into project deliverables
- →Coordinate with Engineering, Quality Assurance, Operations, and Maintenance to support commissioning, start-up, and qualification activities
- →Maintain validation status of systems through the execution of Periodic Reviews, Requalifications, and Change Controls
- →Maintain Validation Master Plans and participate in Validation Review Board meetings
- →Support regulatory inspections and internal audits related to equipment, utility, and facility qualification
