Senior Aseptic Processing Contamination Consultant

About the role

This is a Contract position based in Baltimore, MD. The Principal Aseptic Processing Contamination Consultant provides full-time technical leadership to evaluate high-risk aseptic interventions and identify risk reduction opportunities across syringe, vial, and lyophilization operations in a modern sterile pharmaceutical manufacturing environment.

Responsibilities

• Facilitate intervention assessment workshops five days per week to systematically evaluate high-risk aseptic interventions.
• Lead the evaluation of high-risk interventions using PDA I-REM methodology, contamination control strategy principles, Annex 1 expectations, and FDA aseptic processing guidance.
• Analyze contamination mechanisms associated with first-air disruption,