What are the responsibilities and job description for the Qualification and Validation Specialist position at Advantage Technical?
Qualification and Validation Specialist
Position Type: Contract
Position Location: Birmingham, AL
Position Salary: $80/HR - $85/HR (Depending on Experience)
Responsibilities:
- Support qualification of new equipment intended for GMP operations related to a process scale up.
- 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.
Requirements:
- Bachelor’s degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.
- 3 years of experience in validation / qualification of aseptic pharmaceutical processes and / or equipment.
- 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
- Excellent interpersonal skills
- Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the company
- Comprehensive knowledge of pharmaceutical manufacturing equipment and processes
- Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughly
- Additionally, knowledge of computer system validation, cleaning and sterilization processes are a plus:
Salary : $80 - $85