Our client is hiring a Senior Aseptic Processing & Contamination Control Consultant to provide technical leadership for a 2-month (approx. 12-week) full-time contract project addressing FDA 483 audit findings. In this role, you will perform a thorough review and risk assessment of legacy aseptic fill-finish processes (focusing on non-isolator, manual assembly environments and first air challenges). You will facilitate risk assessment workshops and guide the execution of FMEA models across 100+ high-risk manual interventions to identify contamination mechanisms and drive risk reduction strategies via the eliminate-replace-reduce-control engineering hierarchy in support of CAPA-102537, CAPA-102539, and ICP-100445.
Experience:
- 15+ years of sterile manufacturing and legacy aseptic systems experience (manual assembly, open RABS/laminar flow environments)
- Deep aseptic processing expertise and FMEA risk profile model execution
- First air principles specialist
- Contamination control expert
- Strong documentation skills
- Aseptic risk assessment workshop facilitation
- Application of eliminate-replace-reduce-control risk reduction hierarchy
Day-to-Day Responsibilities:
- Facilitate risk assessment workshops to map detailed step-by-step process executions (e.g., ~25-step manual interventions) in legacy, non-isolator aseptic systems.
- Identify specific contamination mechanisms and first air disruption risks across legacy manual assembly environments.
- Perform Failure Mode and Effects Analysis (FMEA) to calculate Risk Priority Numbers (RPN) and quantify risk drivers for high-risk interventions.
- Drive risk reduction strategies using the eliminate-replace-reduce-control engineering hierarchy to establish interim and long-term mitigations.
The company provides sterile injectables and offers clinical and commercial non-viral aseptic fill/finish services for vials and pre-filled syringes on four fill lines, in addition to lyophilization, terminal sterilization, analytical, stability, packaging and serialization, and additional support services.