Validation Engineer

Job Title:
Validation Engineer – Sterile / Injectable

Location:
Boca Raton, FL

Duration: 12 months with strong possibilities of extension/conversion to full-time

• Role Summary
• Support aseptic process validation activities for sterile injectable products with a strong focus on vial filling and fill-finish operations in a cGMP manufacturing environment.
• Key Responsibilities
• Support aseptic process validation for sterile injectable and vial filling operations.
• Execute and document media fills, process validations, and cleaning validations.
• Prepare and review 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.
• Ensure compliance with cGMP, FDA, and regulatory requirements.
• Collaborate with Manufacturing, QA, and Engineering 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.
• Strong documentation and technical writing skills.