Validation Specialist

Validation Specialist
Job ID
134819
Job Type
Contract
Industry
Manufacturing
Location
Birmingham, Alabama, United States Talascend is currently seeking a Validation Specialist for a contract opportunity with our client in Birmingham, Alabama. Overview The validation specialist will develop user requirement specifications, system impact classifications, and system risk assessments for aseptic facilities and equipment. The role involves conducting risk assessments, developing commissioning and installation qualification protocols, and executing operational and performance qualification activities to verify system operations and compliance. Responsibilities Develop user requirement specifications (URS), system impact classifications (SIC), and system risk assessments (SRA) for 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 correct installation and adherence to specifications.
Perform operational qualification (OQ) and performance qualification (PQ) activities to verify system operation under all conditions.
Perform CSV test script execution to verify system functionality and ensure compliance with predefined acceptance criteria.
Document all test results with objective evidence, including reports and screenshots.
Manage discrepancies identified during IQ, OQ, PQ, CSV, ensuring resolution and documentation.
Collaborate effectively with other workgroups to complete projects on time and thoroughly.
Work independently or within a team environment with effective communication skills to clearly convey observations and outcomes.
Use word processing, spreadsheet, presentation software, and system tools such as Kaye Validator AVS and Val Probe Systems. Qualifications Experience developing URS, SIC, and SRA documentation for aseptic equipment and facilities.
Knowledge of equipment qualifications including homogenizers, pump skids, SIP & CIP skids, temperature control units, pressure vessels, and WFI skids.
Proficient in executing CSV test scripts and documenting results.
Effective written and verbal communication skills. We thank all applicants for their interest. However, only those qualified individuals who closely meet the qualifications of the position will be contacted. The details of the position are only a summary, other duties may be assigned as necessary. Background Check and Drug Screen may be required.