Thermal CQV Engineer – GMP Validation Leader

Amaris Consulting; Toronto; On-site; CAD 90,000 - 120,000; Full time

Job summary

A global consulting firm in Toronto is seeking a Thermal Validation & CQV Engineer to lead thermal validation activities in a GMP-regulated environment. The ideal candidate has 3-10+ years of experience, proficiency in Kaye AVS, and a strong technical background. This role entails collaborating with multiple teams and providing mentorship to junior staff, ensuring compliance and accuracy in validation processes.

Benefits

International community with diverse backgrounds

Strong internal training system

Dynamic work environment with team events

Qualifications

• 3-10+ years of CQV/CSV experience in GMP pharmaceutical or biotech
• Strong hands-on experience with thermal validation and data acquisition
• Excellent technical writing and statistical analysis skills

Responsibilities

• Lead CQV activities for facilities and equipment across operations
• Develop and perform thermal validation for sterilization systems
• Collaborate closely with multidisciplinary teams to ensure GMP compliance

Skills

Thermal cycle development

Temperature mapping

Problem-solving

Technical writing

Data analysis

Education

Bachelor’s degree in Engineering or related discipline

Tools

Kaye AVS

Kneat

Veeva Vault

Job description

A global consulting firm in Toronto is seeking a Thermal Validation & CQV Engineer to lead thermal validation activities in a GMP-regulated environment. The ideal candidate has 3-10+ years of experience, proficiency in Kaye AVS, and a strong technical background. This role entails collaborating with multiple teams and providing mentorship to junior staff, ensuring compliance and accuracy in validation processes.