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.