Validation Engineer – Aseptic​/Sterile Injectables

Overview

Title: Validation Engineer – Aseptic / Sterile Injectables

Role Summary

The Validation Engineer will support aseptic process validation activities for sterile injectable products within a cGMP manufacturing environment. This role focuses heavily on vial filling and fill-finish operations, ensuring validated, compliant, and robust manufacturing processes.

• Support aseptic process validation for sterile injectable manufacturing, with emphasis on vial filling and fill-finish operations.
• Execute and document media fills, process validations, and cleaning validations.
• Author, review, and approve IQ/OQ/PQ protocols, validation plans, and final reports.
• Support validation of aseptic vial filling lines, including filling, stoppering, and capping processes.
• Participate in deviation investigations, root cause analysis, CAPA activities, and risk assessments related to validation.
• Ensure validation activities comply with cGMP, FDA, and applicable regulatory requirements.
• Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, and other stakeholders during validation execution.

• 4–8 years of hands-on validation experience within 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 industry best practices.
• Excellent documentation, technical writing, and communication skills.