Validation Specialist

Sanofi Group; Old Toronto; On-site; CAD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Validation Specialist to enhance healthcare solutions through rigorous validation practices. This role involves ensuring compliance with regulatory requirements, managing validation activities, and leading a team dedicated to maintaining high-quality standards. You will play a pivotal role in developing validation strategies and documentation, collaborating with local and global teams, and supporting inspections. Join a forward-thinking organization that values your expertise and offers a supportive environment for your career growth in the biopharmaceutical field.

Benefits

Comprehensive Benefits

Career Growth Opportunities

Supportive Work Environment

Qualifications

• 5+ years in biopharmaceutical validation, preferably in biological manufacturing.
• Strong knowledge of GxP standards and regulatory compliance.

Responsibilities

• Validate and manage computerized systems at the site.
• Provide validation expertise using a risk-based approach.
• Develop validation strategies and documentation.

Skills

Regulatory Compliance

Validation Management

Risk Management

Data Analysis

GxP Standards

Education

Bachelor's in Engineering

Bachelor's in Science

Job description

Reference No. R2796200

Position Title: Validation Specialist

Department: Computerized System Validation

Duration: Fixed Term Contract End Date: November 20, 2028

Location: Toronto, Ontario

About the Job

We deliver 4.3 billion healthcare solutions annually, thanks to our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect against infectious diseases and bring hope to patients and families.

The role involves providing guidance on regulatory requirements, acting as a sponsor for Quality practices related to computerized systems, and making decisions and recommendations on validation activities, strategies, and procedures. You will interpret regulatory guidelines and participate in validation strategies to ensure operations are validated, including oversight of protocol development, execution, and documentation approval.

Main Responsibilities

• Validation Management - 70%

• Validate and manage computerized systems at the site.
• Provide validation expertise using a risk-based approach, coordinate risk assessments, and support system maintenance to keep systems validated.
• Develop validation strategies and documentation to meet regulatory and business requirements.
• Review and approve validation-related documents, ensuring compliance.
• Lead and manage validation personnel, providing guidance and support.
• Collaborate with consultants to meet Sanofi Pasteur standards.

• Validation Resource - 10%

• Provide leadership on regulatory requirements and quality practices, support supplier audits, and develop validation procedures.

• Global & Local Quality Initiatives - 10%

• Represent Quality Operations on projects, participate in quality initiatives, and stay updated on industry regulations.

• External Compliance & Inspection Support - 10%

• Coordinate with regulatory personnel, support inspections, and ensure policies align with regulations.

Training & Communication

Provide training on validation activities, communicate effectively with management and teams, and ensure documentation and metrics are maintained.

Periodic Review & Challenges

Lead periodic reviews of computerized systems, develop strategies for complex validation projects, and prioritize activities based on risks and project needs.

Qualifications & Skills

• Bachelor's in engineering or science.
• 5+ years in biopharmaceutical validation, preferably in biological manufacturing.
• Knowledge of GxP standards, validation, data analysis, and risk management.

Why Join Us?

• Contribute to life-changing healthcare solutions.
• Grow your career with global opportunities.
• Enjoy comprehensive benefits and a supportive environment.

Sanofi is an equal opportunity employer promoting diversity and inclusion. Accommodations are available upon request during recruitment.