Airswift is looking for a Commissioning & Qualification Specialist to work with one of our major chemical manufacturing clients in Birmingham, AL, for a 6-month assignment with possible extension.
Job Responsibilities:
- 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 systems are installed correctly and meet specified requirements.
- Perform Operational Qualification (OQ) and Performance Qualification (PQ) activities to verify systems operate as intended under all operating conditions.
- Possess knowledge and hands-on experience with qualification of the following equipment:
- Homogenizers
- Pump Skids
- SIP & CIP Skids
- Temperature Control Units
- Pressure Vessels
- WFI Skids
- Execute Computer System Validation (CSV) test scripts to verify system functionality in compliance with predefined acceptance criteria.
- Document all test results with objective evidence, including screenshots, reports, and other supporting documentation as required.
- Identify, document, and manage discrepancies identified during IQ, OQ, PQ, and CSV activities, ensuring proper resolution and traceability.
- Collaborate closely and effectively with cross-functional teams to ensure projects are completed on time and meet quality expectations.
- Work independently or as part of a team in a dynamic project environment.
- Demonstrate strong written and verbal communication skills, with the ability to clearly communicate observations, issues, and outcomes to all organizational levels.
- Exhibit proficiency in word processing, spreadsheet, and presentation software.
- Demonstrate proficiency in the use of Kaye Validator AVS and Val Probe Systems.
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