Validation Specialist

Plan and schedule all required activities according to departmental priorities.

Establish work processes to ensure deadlines are met, and coordinate all qualification and validation activities

Write validation protocols related to the equipment, based on protocol templates already in place.

Manage the review and approval of protocols.

Perform all validation activities for equipment and systems.

Work with the validation team to resolve gaps and deficiencies.

Create standard test procedures for the equipment and standardize engineering documents related to testing and validation.

Participate in the first run of systems and equipment. Participate in engineering tests (tests during installation) and acceptance tests.

Participate, revise, or draft various documents according to GMP standards.

Autonomous

Good knowledge of French (oral and written)

Must be master of the English language and be able to produce high quality documentation in English

Ability to work in a team and have good communication skills

Knowledge of Office applications: Microsoft Word, Excel.

Intermediate level in computer skills

Good mechanical knowledge (Asset)

Knowledge of GMP and ISO (Asset)