Validation Engineer

Job Title: Validation Engineer Location: New York Duration: 12+ Months (Contract)

Experience: 5 - 7 Years

About the Role

We are seeking a Validation Engineer to lead smoke studies in support of aseptic drug product manufacturing. This role will be responsible for ensuring compliance with FDA, EMA, Annex 1, and ISO standards while driving airflow visualization initiatives.

Responsibilities

• Conduct airflow visualization for cleanrooms, isolators, biosafety cabinets, and filling lines.

• Support validation of utilities including AHUs, gas systems, autoclaves, and parts washers.

• Perform Environmental Monitoring testing.

• Generate accurate documentation, protocols, and reports.

• Collaborate with Quality, Facilities, and Manufacturing teams to maintain contamination control compliance.

Requirements

• 5+ years of validation or engineering experience in pharmaceutical or biotechnology environments.

• Direct hands-on smoke study experience in sterile/aseptic manufacturing.

• Strong understanding of HEPA systems, airflow principles, and cleanroom design.

• Knowledge of global regulatory requirements including FDA, EMA, ISO, and Annex 1.

• Proven ability to produce clear documentation and communicate effectively across teams.

• Must be able to provide two prior manager references.