Experienced Validation Engineer Sterile Manufacturing

Position: Experienced Validation Engineer for Sterile Manufacturing
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:

• Bachelor's degree in Science or related field

• 7–10 years in GMP-regulated environments

• Expertise in sterile and aseptic processes

• Strong knowledge of EU GMP Annex 1 and FDA guidelines

• Excellent technical writing and cross-functional skills

Utilize your validation expertise to ensure the highest quality in sterile manufacturing at Amaris Consulting in Toronto.
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