Role Overview

Key Responsibilities

• Lead annual performance qualification activities for sterilization and depyrogenation equipment, including protocol development, execution, and reporting.
• Develop and execute qualification protocols for equipment, systems, computerized systems, laboratory instruments, and utilities.
• Prepare detailed validation protocols that include critical parameters, acceptance criteria, and sampling methodologies.
• Assess the impact of equipment, raw material, or manufacturing process changes on validated systems and determine revalidation requirements.
• Develop cleaning validation protocols in compliance with Health Canada, FDA, and EMA requirements.
• Conduct risk assessments to justify cleaning limits and identify critical process parameters.
• Participate in periodic qualification programs according to established procedures and timelines.
• Review, write, and update standard operating procedures, work instructions, and forms.
• Ensure protocols and reports comply with corporate standards and current Good Manufacturing Practices (cGMP).
• Manage qualification projects in alignment with project plans, timelines, and the Validation Master Plan.
• Provide validation support during the design, installation, commissioning, startup, and operation of new and existing equipment, systems, and utilities.
• Participate in equipment evaluation, selection, and procurement activities.
• Support new product introductions, quality investigations, CAPA activities, and change control assessments.
• Execute decommissioning activities as required.
• Perform additional duties as assigned.

Qualifications

• Bachelor's degree in Engineering or Science.
• Minimum three (3) years of experience in pharmaceutical manufacturing.
• Hands-on experience writing qualification documentation and engineering studies.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices.
• Proficiency in Microsoft Office applications.
• Proficiency with Kaye Validator software and instruments.
• Bilingual in French and English, as the role supports operations outside of Quebec
• Strong interpersonal and collaboration skills.
• Quality-focused with exceptional attention to detail.
• Strong analytical and problem-solving capabilities.
• Membership in the Ordre des ingénieurs du Québec (OIQ) is considered an asset.
• PMP certification is considered an asset.