Validation Engineer – Lyophilization Specialist
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-01-25
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-01-25
Job specializations:
-
Pharmaceutical
Validation Engineer, Pharma Engineer, Pharmaceutical Manufacturing, Quality Engineering -
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
Overview
Seeking a hands-on Sterilization Validation Engineer with strong expertise in lyophilization (freeze-drying) to support sterile pharmaceutical manufacturing operations. This role is execution-focused and involves on-the-floor commissioning, qualification, and sterilization validation of lyophilizers, isolators, and autoclaves within a GMP environment.
Required Experience- Sterilization Validation experience in GMP pharmaceutical or biopharmaceutical manufacturing
- Strong expertise in lyophilization (freeze-drying) equipment and processes
- Hands-on execution of IQ, OQ, and especially PQ for lyophilizers
- Experience with isolator-based sterile fill-finish systems
- Autoclave qualification and sterilization validation experience
- Hands-on experience using Kaye’s or Ellab thermal mapping systems
- Ability to work onsite and perform floor-level execution
- Execute IQ, OQ, and PQ protocols for lyophilizers and associated sterile equipment
- Perform sterilization and sterility validation activities
- Execute autoclave qualification and thermal mapping studies
- Provide on-the-floor support during validation execution and testing
- Ensure compliance with GMP and sterility assurance requirements
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