Validation Engineer

Responsibilities Execute Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ) activities for aseptic fill‑finish manufacturing equipment in a GMP‑regulated pharmaceutical environment. Develop, review, and execute validation protocols, test scripts, and final reports for fill‑finish systems, formulation equipment, preparation vessels, and supporting utility systems. Perform qualification activities for critical manufacturing equipment, including isolators, autoclaves, parts washers, filling machines, and associated process systems. Conduct smoke studies and airflow pattern analyses to verify aseptic processing conditions and ensure compliance with regulatory requirements and industry standards. Support startup and commissioning activities for new manufacturing line installations by verifying equipment installation, functionality, and operational readiness. Collaborate with Engineering, Manufacturing, Quality Assurance (QA), and Automation teams to resolve validation issues, investigate deviations, and implement Corrective and Preventive Actions (CAPA). Generate, review, and maintain GMP documentation, including validation protocols, summary reports, risk assessments, change controls, deviation investigations, and Standard Operating Procedures (SOPs). Analyze qualification and validation data to ensure equipment and processes consistently meet predefined acceptance criteria, regulatory requirements, and product quality standards. Support formulation, preparation, and fill‑finish process validation activities by evaluating critical process parameters and ensuring process reproducibility and consistency. Ensure compliance with FDA, cGMP, ICH, and company quality requirements throughout all phases of the validation lifecycle. Participate in regulatory inspections and internal audits by providing validation documentation, technical support, and subject‑matter expertise. Conduct gap assessments and drive continuous improvement initiatives to enhance validation processes, equipment reliability, operational efficiency, and overall manufacturing compliance. #J-18808-Ljbffr