Job Title

Process Validation Engineer – Sterile Fill Finish / Pre-Filled Syringes (PFS)

Job Summary

We are seeking an experienced Process Validation Engineer to support multiple strategic projects within a pharmaceutical manufacturing environment. The successful candidate will lead process validation activities for new and existing Pre-Filled Syringe (PFS) fill lines, including Process Performance Qualification (PPQ), aseptic process validation, media fills, and technology transfer initiatives. This role requires extensive experience in sterile manufacturing, cGMP compliance, and cross-functional collaboration to ensure robust, compliant, and efficient manufacturing processes.

Key Responsibilities

• Develop and execute process validation strategies for new sterile fill-finish manufacturing projects.
• Lead Process Performance Qualification (PPQ) studies to demonstrate consistent and reproducible manufacturing process performance.
• Plan, author, review, and execute validation protocols and reports, including Process Validation Plans, PPQ Protocols, Validation Summary Reports, and Risk Assessments.
• Support technology transfer activities by implementing manufacturing processes from development to commercial production on new and existing PFS fill lines.
• Coordinate cross-functional teams during tech transfer activities involving Manufacturing, MSAT, Engineering, Quality, Validation, and Regulatory Affairs.
• Perform process revalidation activities for existing Pre-Filled Syringe (PFS) manufacturing lines.
• Coordinate, execute, and evaluate aseptic media fill simulations to verify sterility assurance and aseptic process performance.
• Support smoke studies to evaluate airflow patterns, unidirectional airflow, and aseptic process integrity within classified manufacturing environments.
• Plan and support qualification activities for automated visual inspection (AVI) systems, including IQ, OQ, PQ, and performance verification.
• Conduct process risk assessments using tools such as FMEA and implement mitigation strategies to minimize process risks.
• Analyze validation data, investigate deviations, perform root cause analysis, and implement CAPAs when required.
• Review batch records, process data, environmental monitoring results, and validation documentation to ensure regulatory compliance.
• Collaborate with clients and external partners during technology transfer, validation planning, and project execution.
• Support equipment qualification and commissioning activities associated with sterile fill-finish manufacturing systems.
• Ensure compliance with cGMP, FDA, EMA, ICH, EU Annex 1, and company quality standards throughout validation activities.
• Participate in change control, deviation management, and continuous process improvement initiatives.
• Support regulatory inspections and internal audits by providing validation documentation and technical expertise.
• Monitor project timelines, validation milestones, and deliverables to ensure successful project execution.