Elevate your career as a Senior Validation Engineer with Amaris Consulting in Toronto, ON. This hybrid role centers on sterile manufacturing quality validation and environmental monitoring.
As an experienced Senior Validation Engineer, you will lead critical validation efforts for a new aseptic filling facility. Your expertise will drive compliance with GMP regulations in environmental monitoring, isolator qualification, and aseptic process simulation studies. Collaborate with cross-functional teams to ensure the success of validation activities aligned with manufacturing operations.
Key Responsibilities:
• Lead Environmental Monitoring validation for sterile facilities
• Serve as SME for isolator qualification activities
• Design and execute validation strategies
• Develop and validate EM sampling plans and alerts
• Collaborate across Engineering, Manufacturing, and Microbiology teams
Requirements:
• Bachelor's degree in Science or Engineering
• 7–10 year...