VALIDATION SPECIALIST

1. JOB OBJECTIVES

• Supervise, draft, plan, and execute various protocols to ensure the validation of all systems, equipment, facilities, and processes in compliance with applicable standards and regulations.

• Provide training and support to technologists on validation principles.

2. PRIMARY FUNCTIONS

• Draft, review, and approve validation protocols for equipment, systems, facilities, cleaning, and processes.

• Ensure that validation protocols comply with the rationale, strategies, methodologies, and acceptance criteria defined by the department.

• Coordinate and plan the execution of validation protocols.

• Analyze, compile results, and approve validation protocols and reports.

• Plan the use of internal resources and coordinate their activities to meet established timelines.

• Propose methods to improve departmental work processes.

• Draft and review Standard Operating Procedures (SOPs) related to the department.

• Provide technical support to other departments.

• Keep management informed of activities under their responsibility.

• Perform any other related tasks deemed relevant to the position.

3. EXPERIENCE REQUIREMENT AND APTITUDES

• Bachelor’s degree in engineering or sciences, or any other equivalent education;

• 7–10 years of experience in the pharmaceutical industry or a related field;

• Autonomous, organized, strong analytical skills, and leadership abilities;

• Excellent oral and written communication skills in both French and English (bilingual);

• Solid knowledge of Canadian Good Manufacturing Practices (GMP) and international standards;

• Proficiency in MS Office software (Word, Excel, PowerPoint);

• Ability to work in a team;

• Manual dexterity.