Role Overview

The Validation Specialist is responsible for developing, coordinating, and executing qualification and validation activities related to equipment, systems, utilities, cleaning processes, and manufacturing operations. This role partners closely with cross-functional teams to ensure compliance with regulatory requirements and current Good Manufacturing Practices (cGMP).

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 Positive 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.

📌 Validation Specialist (Kirkland)
🏢 Jubilant DraxImage
📍 Kirkland