Commissioning and Qualification Specialist
- Develop User Requirement Specifications (URS), System Impact Classifications (SIC), and System Risk Assessments (SRA) for new and existing aseptic facilities and equipment.
- Conduct risk assessments and implement mitigation strategies for aseptic processes.
- Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols to ensure that systems are installed correctly and meet specifications.
- Perform operational qualification (OQ) and performance qualification (PQ) activities to verify that systems operate as intended under all conditions.
- Knowledge of the following equipment qualifications: Homogenizers Pump Skids SIP & CIP Skids Temperature control units Pressure Vessels WFI Skid Perform CSV test script execution to verify system functionality, ensuring compliance with predefined acceptance criteria.
- Document all test results with objective evidence, including screenshots, reports, and other supporting materials as necessary.
- Document and manage any discrepancies identified during IQ, OQ, PQ, CSV, ensuring proper resolution and documentation.
- Work closely and effectively with other workgroups to successfully complete projects on time and thoroughly.
- Work independently or within a team environment.
- Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the Company.
- Proficient in the use of word processing, spreadsheet and presentation software programs.
- Proficient in using Kaye Validator AVS and Val Probe Systems.
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