Validation Specialist

• 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.

Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a closely related field, and 2 years of experience in pharmaceutical validation, quality systems, or related GMP-regulated environments. Must have hands-on experience conducting equipment qualification (IQ/OQ/PQ) for manufacturing and laboratory equipment. Must have experience with thermal validation using Ellab or equivalent systems, including thermocouple mapping and lethality validation. Must have experience leading or supporting sterilization validation (e.g., SIP, depyrogenation, or aseptic process simulations) aligned with ISO 17665 and PDA guidelines. Must have experience with computerized system validation (CSV) in accordance with 21 CFR Part 11, GAMP 5, and Data Integrity (ALCOA+) principles. Must have experience in process validation (PV) and continued process verification (CPV), including protocol drafting, sampling plans, execution, and statistical analysis. Must have experience in cleaning validation, including MACO and PDE-based limit calculations, toxicological risk assessments, and swab sampling strategies. Must have experience with statistical tools, including JMP, for data analysis, trend monitoring, and process capability assessments. Must have experience working with cloud-based system migrations and enterprise platforms (including SAP, Empower, MODA, and Fiix). Must have experience with Quality Management Systems (QMS), including document control, audit trail review, and deviation/CAPA processes. Must have experience with FDA 21 CFR Parts 210, 211, 820, EU Annex 1, and relevant ICH and PDA regulatory standards. Must have good written and verbal communication skills in English.