Process Validation Engineer

Key Responsibilities

• Develop and execute process validation strategies for new and existing fill-finish manufacturing lines.
• Lead Process Performance Qualification (PPQ) activities to demonstrate process consistency, reliability, and regulatory compliance.
• Support revalidation activities for pre-filled syringe (PFS) filling lines and associated manufacturing processes.
• Cook up and evaluate aseptic media fill studies to ensure process integrity and contamination control.
• Plan and conduct smoke studies to verify airflow patterns and aseptic processing conditions.
• Collaborate with Manufacturing, Quality, Engineering, Validation, and external stakeholders to ensure successful project execution.
• Support technology transfer projects by implementing manufacturing processes across new and existing production lines.
• Participate in risk assessments, protocol development, execution, deviation management, and final reporting.
• Ensure all validation documentation complies with cGMP, FDA, and regulatory requirements.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Experience in pharmaceutical process validation within aseptic manufacturing environments.
• Hands-on experience with:
• Process Validation
• Process Performance Qualification (PPQ)
• Aseptic Media Fills
• Smoke Studies
• Technology Transfer
• Experience supporting pre-filled syringe (PFS) manufacturing operations.
• Strong understanding of cGMP regulations and validation lifecycle activities.
• Excellent communication and cross-functional collaboration skills.