Commissioning and Qualification Specialist
Sirius Technical Services, Inc., Birmingham, AL, United States
Sirius Staffing is seeking a
Commissioning and Qualification/Validation Specialist
to support the qualification, commissioning, and validation of new equipment for GMP operations in support of process scale‑up within a pharmaceutical manufacturing environment.
$80-85/hr + Benefits Offered, PTO & Holiday Pay
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 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.
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.
Work closely and effectively with other workgroups to successfully complete projects on time and thoroughly.
Requirements
Bachelor’s degree preferably in a Science or Engineering discipline. Other disciplines may be considered with proven experience.
3+ years of experience in validation/qualification of aseptic pharmaceutical processes and/or equipment.
Proficient in using Kaye Validator AVS and Val Probe Systems.
Comprehensive knowledge of pharmaceutical manufacturing equipment and processes.
Strong understanding of Regulatory Guidance Framework, FDA/EU, FDA 21 CFR Part 11, Industry Best Practices, and cGMPs.
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.
Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all within the company.
Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughly.
Proficient in the use of Microsoft Office applications, Word, Excel, and PowerPoint.
Knowledge of computer system validation, cleaning, and sterilization processes is a plus.
Knowledge of the following Equipment qualifications:
Homogenizers
Pump Skids
SIP & CIP Skids
Temperature control units
Pressure Vessels
WFI Skid
Sirius Staffing is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.
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Commissioning and Qualification/Validation Specialist
to support the qualification, commissioning, and validation of new equipment for GMP operations in support of process scale‑up within a pharmaceutical manufacturing environment.
$80-85/hr + Benefits Offered, PTO & Holiday Pay
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 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.
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.
Work closely and effectively with other workgroups to successfully complete projects on time and thoroughly.
Requirements
Bachelor’s degree preferably in a Science or Engineering discipline. Other disciplines may be considered with proven experience.
3+ years of experience in validation/qualification of aseptic pharmaceutical processes and/or equipment.
Proficient in using Kaye Validator AVS and Val Probe Systems.
Comprehensive knowledge of pharmaceutical manufacturing equipment and processes.
Strong understanding of Regulatory Guidance Framework, FDA/EU, FDA 21 CFR Part 11, Industry Best Practices, and cGMPs.
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.
Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all within the company.
Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughly.
Proficient in the use of Microsoft Office applications, Word, Excel, and PowerPoint.
Knowledge of computer system validation, cleaning, and sterilization processes is a plus.
Knowledge of the following Equipment qualifications:
Homogenizers
Pump Skids
SIP & CIP Skids
Temperature control units
Pressure Vessels
WFI Skid
Sirius Staffing is an equal‑opportunity employer. All qualified applicants will receive consideration for employment without regard to characteristics such as race, color, national origin, religion, gender, age, marital status, disability, veteran status, citizenship status, sexual orientation, gender identity, or any other status protected by law.
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