Validation Specialist

at Argenta US Manufacturing, LLC in Shawnee, Kansas, United States

Job Description

Duties: Develop User Requirement Specifications (URS), Functional Requirements (FRS), Configuration/Design Specifications, Risk Assessments, Requirement Traceability Matrices (RTMs), Validation Plans (VMP), Test Plans, and Validation Summary Reports (VSR).  Execute validation lifecycle documents including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for both manufacturing and laboratory systems.  Lead and support Process Validation (PV) activities: define sampling plans, verify Critical Process Parameters (CPPs), collect in-process and final product samples, and compile validation reports per ICH Q8–Q10. Support and execute Aseptic Process Simulations (Media Fills), including operator qualification, process simulation design, and result evaluation in compliance with sterility assurance standards.  Perform Cleaning Validation, including swab sampling strategy, MACO/PDE-based residue limit calculations, and execution of cleaning protocols. Conduct validation of thermal processes such as Steam-in-Place (SIP) and Depyrogenation tunnels, including thermocouple mapping, endotoxin challenge studies, and F0 calculation using tools such as Ellab. Facilitate risk assessments for GxP computerized systems, ensuring compliance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) guidelines.  Execute retrospective validation for legacy systems and close compliance gaps via change control, system remediation, and updated documentation.  Support cloud-based system transitions and data migrations for systems such as SAP ByDesign, MODA, Empower, ZenQMS, and Fiix, ensuring business continuity and data integrity. Perform Continued Process Verification (CPV), using statistical tools such as JMP for trend analysis, control charting, and capability studies (Cp/Cpk).  Serve as a validation representative during internal and regulatory audits; address audit findings through CAPAs and technical document revisions.  Draft and review Standard Operating Procedures (SOPs), Risk Assessments, and final validation documentation for various qualification and compliance activities.  No hire/fire authority.