Senior Validation Engineer – Sterile Manufacturing & Quality Validation

Job description

We are seeking an experienced Senior Validation Engineer to support a large-scale pharmaceutical manufacturing expansion project focused on sterile manufacturing operations. This role will play a critical part in validation, environmental monitoring, sterility assurance, and quality oversight activities associated with a new aseptic filling facility and supporting infrastructure.

The successful candidate will provide technical leadership for environmental monitoring validation, isolator qualification, aseptic process simulation studies, and equipment qualification while ensuring compliance with current GMP regulations and industry best practices.

Location

Toronto, ON, Canada (Hybrid)

Key Responsibilities

• Lead the development, execution, and reporting of Environmental Monitoring (EM) validation programs for sterile manufacturing facilities.
• Serve as Subject Matter Expert (SME) for isolator qualification ...