Shoolin Inc · 8 hours ago
Validation Engineer – Lyophilization Specialist
New York, United States
Contract
Onsite
Mid LevelShoolin Inc is seeking a hands-on Sterilization Validation Engineer with strong expertise in lyophilization to support sterile pharmaceutical manufacturing operations. This role involves on-the-floor commissioning, qualification, and sterilization validation of lyophilizers, isolators, and autoclaves within a GMP environment.
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Hiring Manager
Aadil Shaikh
Responsibilities
Execute IQ, OQ, and PQ protocols for lyophilizers and associated sterile equipment
Perform sterilization and sterility validation activities
Support lifecycle development activities for sterile systems
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
Qualification
Required
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
Extensive PQ execution experience
Hands-on experience using Kaye's or Ellab thermal mapping systems
Ability to work onsite and perform floor-level execution
Company
Shoolin Inc
Shoolin-Inc staffing, specializes in providing world class recruiting services to companies in the Healthcare, IT, and Engineering sectors.
Founded in 2010
51-200 employees
H1B Sponsorship
Shoolin Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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2025 (81)
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2021 (29)
2020 (18)
Funding
Current Stage
Growth StageCompany data provided by crunchbase