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Senior Specialist, Equipment and System Validation
4 weeks ago
The Equipment and Systems Validation Specialist plays a crucial role in the validation of complex equipment/systems at the Royalmount and Dorval site. As a team member, they will collaborate with other validation team members on their projects. The Specialist acts as a validation project manager, ensuring that all stages of the project are followed in accordance with standard procedures (health and safety, Good Manufacturing Practices, etc.). They coordinate activities of all involved parties: professionals, entrepreneurs, consultants, regulatory bodies, and act as a liaison to internal clients. The Equipment and Systems Validation Specialist reviews and approves the documents (protocols and reports) from the Validation Specialists.
Responsibilities & Duties
- Develop validation protocols – installation, operational, and performance qualification and requalification
- Execute or supervise the execution of the protocol tests
- Manage the revision and approval of protocols
- Manage the documentation related to validation activities (filing, update, and preparation)
- Participate in the resolution of deviations and deficiencies
- Participate in audits as a validation expert
Skills, Knowledge & Abilities
- Ability to manage multiple projects simultaneously
- Ability to review and approve technical reports efficiently
- Ability to write technical reports in a neat and concise manner
- Capacity to manage pressure and adapt to change
- Possess a good sense of communication and urgency (prioritization)
- Enjoy teamwork and exchanges
- Capable in software tools such as Microsoft Office, Outlook
