Engineer Validation Operations

6 Months – CSV – cGMP

The Engineer, Validation Operations performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures. They are authorized to direct external vendors performing work in this field.

In addition, the Engineer, Validation Operations is the backup of the Project Engineer And C&Q Supervisor for all Engineering and C&Q topics.

Your Responsibilities:

• Ensure equipment and systems are qualified, validated and maintained in compliance with the regulations
• Execute qualifications/validations or supervising external workers for all equipment and systems across the site, including QC, warehouse, facilities, lab equipment, utilities, and computer system validation,
• Review/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
• Support internal and external audit requests
• Author and when required review qualification/validation documents, including requirement specifications, qualification/validation plans, protocols, reports, traceability matrix and summary reports.

Your Profile:

• Required: proven experience on utilities qualification: purified water
• 5+ years of experience in pharmaceutical Validation
• Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems and computerized system validation (CSV)
• Strong communication skills and ability to work collaboratively
• Good level of English
• Ability to communicate in French is preferred