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Commissioning and Qualification Specialist

Genesis Technical Staffing, Inc

Genesis Technical is seeking a Commissioning and Qualification Specialist for a contract position in Birmingham, AL.

100% Onsite in Bham
  • 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.
Genesis Staffing provides equal employment opportunities (EEO) to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Genesis Staffing and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at

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Vacancy posted 1 day ago
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