Senior Validation Engineer

Overview

Job Title: Validation Engineer – Aseptic / Sterile Injectables

The Validation Engineer will support aseptic process validation activities for sterile injectable products within a cGMP-regulated manufacturing environment. This role has a strong emphasis on vial filling and fill-finish operations, ensuring validated processes meet FDA and regulatory requirements.

• Support aseptic process validation activities for sterile injectable products, including vial filling and fill-finish operations.
• Execute, document, and support media fills, process validations, and cleaning validations.
• Prepare, review, and approve IQ, OQ, and PQ validation protocols and final reports.
• Support validation of aseptic vial filling lines, including filling, stoppering, and capping equipment.
• Participate in deviation investigations, CAPA activities, and risk assessments related to validation processes.
• Ensure all validation activities comply with cGMP, FDA, and applicable regulatory guidelines.
• Collaborate closely with Manufacturing, Quality Assurance, and Engineering teams during validation planning and execution.
• Maintain accurate and compliant validation documentation in accordance with site procedures.

• 4–8 years of hands-on validation experience in sterile injectable manufacturing environments.
• Direct experience supporting aseptic vial filling and fill-finish operations.
• Strong working knowledge of media fills and aseptic process validation.
• Solid understanding of cGMP, FDA regulations, and regulatory expectations for sterile products.
• Excellent technical writing, documentation, and communication skills.