Senior Engineer: Aseptic Process and Compliance

Join Amaris Consulting as a Senior Validation Engineer, specializing in aseptic processing for sterile manufacturing in Toronto, ON. This hybrid role emphasizes quality validation and regulatory compliance in a fast-paced environment.

As a Senior Validation Engineer, you’ll take the lead in validation activities for sterile manufacturing projects at Amaris Consulting. This position demands strong expertise in environmental monitoring, isolator qualifications, and the execution of aseptic process simulation studies. Delivering quality oversight will ensure compliance with GMP and industry standards.

Key Responsibilities: • Execute and report on Media Fill studies • Design and validate APSS protocols and strategies • Review validation deliverables and ensure compliance • Assess deviations and recommend corrective actions • Provide training on quality and validation procedures

Requirements: • Bachelor’s degree in a relevant discipline • 7–10 years experience in ...