Validation Engineer – Aseptic​/Sterile Injectables : Boca Raton, FL; Onsite

Hiring for Validation Engineer – Aseptic / Sterile Injectables

Employment Type: Contract (W2)

Seeking a Validation Engineer with hands‑on experience in aseptic processing and sterile injectable manufacturing. This role will support process validation activities with a strong focus on vial filling and fill‑finish operations in a cGMP‑regulated environment.

• 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 validation of filling, stoppering, and capping processes
• Participate in deviation investigations, CAPA, and risk assessments
• Ensure compliance with cGMP, FDA, and regulatory standards
• Collaborate cross‑functionally with Manufacturing, QA, and Engineering

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