Amaris Consulting
Experienced Validation Engineer for Sterile Manufacturing
Job Description
Take on a crucial role as a Senior Validation Engineer with Amaris Consulting, focusing on sterile manufacturing in Toronto, ON. This hybrid position requires expertise in validation and compliance for large-scale pharmaceutical operations.
Amaris Consulting is looking for a highly skilled Senior Validation Engineer to support a major pharmaceutical project in Toronto. You will lead environmental monitoring validations, isolator qualifications, and aseptic process simulations while ensuring compliance with GMP regulations. This role requires hands-on experience in equipment qualification and a commitment to quality assurance.
Key Responsibilities: • Lead Environmental Monitoring (EM) validation programs execution • Serve as SME for isolator qualification activities • Design validation strategies like airflow and cleanroom qualification • Develop EM sampling plans and alert limits • Collaborate across teams for facility start-up processes
Requirements: • Bache...
Amaris Consulting is looking for a highly skilled Senior Validation Engineer to support a major pharmaceutical project in Toronto. You will lead environmental monitoring validations, isolator qualifications, and aseptic process simulations while ensuring compliance with GMP regulations. This role requires hands-on experience in equipment qualification and a commitment to quality assurance.
Key Responsibilities: • Lead Environmental Monitoring (EM) validation programs execution • Serve as SME for isolator qualification activities • Design validation strategies like airflow and cleanroom qualification • Develop EM sampling plans and alert limits • Collaborate across teams for facility start-up processes
Requirements: • Bache...