• 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

Key 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