Commissioning & Qualification Specialist in Birmingham, Alabama, North America

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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. #LI-BF2 If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.