Validation Engineer

We are seeking a Validation Engineer to support aseptic process validation activities for sterile injectable products, with a focus on vial filling and fill-finish operations in a cGMP manufacturing environment.

Key Responsibilities:

• Execute and document media fills, process validations, and cleaning validations.
• Prepare, review, and execute IQ/OQ/PQ protocols and validation reports.
• Support aseptic vial filling line validations, including filling, stoppering, and capping processes.
• Participate in deviation investigations, CAPA, and risk assessments related to validation activities.
• Ensure compliance with cGMP, FDA, and other regulatory requirements.
• Collaborate with Manufacturing, QA, and Engineering teams during validation execution.

Required Skills & Experience:

• 4–8 years of validation experience in sterile injectable manufacturing.
• Hands-on experience with aseptic vial filling operations.
• Strong knowledge of media fills and fill-finish validation.
• Solid understanding of cGMP and FDA regulations.
• Excellent documentation and technical writing skills.