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Commissioning & Qualification Specialist

United States, Birmingham · Job Posted December 16, 2025
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Job Description

Airswift is looking for a Commissioning & Qualification Specialist to work with one of our major clients in Birmingham, AL

Job Responsibility

  • Develop URS, SIC and SRA for new and existing aseptic facilities and equipment
  • Develop and execute Commissioning (COM) and Installation qualification (IQ) protocols
  • Perform operational qualification (OQ) and performance qualification (PQ) activities
  • Ensure all documentation is compliant with regulatory requirements and internal quality standards
  • Conduct risk assessments and implement mitigation strategies for aseptic processes
  • Proficient in the use of word processing, spreadsheet and presentation software programs
  • Proficient in use if Kaye Validator AVS and Val Probe Systems
  • Knowledge on following equipment qualifications: Homogenizers, Pump Skids, SIP & CIP Skids, Temperature control units, Tanks, Requalification of CTU’s
  • Develop and implement validation plans for computerized systems
  • Conduct risk assessments to identify potential issues related to system functionality and data integrity
  • Create and maintain comprehensive documentation, including system classification, system overview, test scripts, and reports
  • Execute CSV protocol, to verify that systems function as intended
  • Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals
  • strong organization skills to handle and delegate multiple projects at differing levels of complexity

Requirements

  • Bachelor’s degree preferably in Engineering or Science discipline
  • 3 to 5 experience in validation / qualification of aseptic pharmaceutical processes and / or equipment
  • Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices and GMPs
  • Comprehensive knowledge of pharmaceutical manufacturing equipment and processes

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