Validation Specialist

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

Job summary

An established industry player is seeking a Validation Specialist to ensure the compliance and validation of computerized systems within their manufacturing environment. This role involves leading validation activities, developing strategies, and providing guidance on regulatory requirements. The ideal candidate will have a strong background in biopharmaceutical manufacturing, excellent project management skills, and a passion for quality assurance. Join a team dedicated to delivering life-changing healthcare solutions and enjoy opportunities for career growth and comprehensive benefits.

Benefits

Comprehensive Benefits

Career Growth Opportunities

Training Programs

Flexible Work Environment

Qualifications

• 5+ years in biopharmaceutical manufacturing with validation knowledge.
• Strong skills in regulatory compliance and quality assurance.

Responsibilities

• Manage validation of computerized systems and ensure compliance.
• Provide training on validation activities and support audits.

Skills

Regulatory Compliance

Validation Strategies

Risk Assessment

Quality Assurance

Project Management

Education

Bachelor's degree in Engineering or Science

Tools

Validation Software

Document Management Systems

Job description

Join to apply for the Validation Specialist role at Sanofi

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 to people every year, thanks to the meticulous planning and detail-oriented approach of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

The purpose of this position is to provide guidance regarding regulatory requirements and act as a sponsor for Quality practices for computerized systems. It involves providing decisions, guidance, and recommendations related to computerized systems, strategies, procedures, and validation activities. The role includes interpreting Regulatory guidelines and regulations for implementing computerized systems, leading or executing validation strategies, and supporting quality processes. The primary responsibility is to ensure the validated state of operations in Manufacturing and Quality Control, including protocol development, execution, and documentation approval.

Main Responsibilities

1. Management of Validation - 70%
2. Validate and manage computerized systems deployed at the site and local site systems.
3. Provide validation expertise and guidance to project teams using a risk-based approach, coordinate risk assessments, and support system maintenance to keep systems validated.
4. Develop validation strategies, test plans, and review documentation to ensure compliance with regulatory and company standards.
5. Lead and manage validation activities and personnel, providing direction and prioritization.
6. Interface with consultants to ensure validation documents meet Sanofi Pasteur’s requirements.
7. Validation Resource - 10%
8. Provide leadership on regulatory requirements and support Quality practices, including participation in supplier audits and development of related procedures.
9. Collaboration on Local & Global Quality Initiatives - 10%
10. Represent Quality Operations on projects, participate in global initiatives, and promote best practices.
11. Support for External Compliance Inspection Activities - 10%
12. Coordinate with personnel for regulatory interpretations, participate in inspections, and ensure consistency in policies and practices.
13. Training and Interactions - 10%
14. Provide training on validation activities, communicate with management, and ensure ongoing monitoring and reporting.
15. Perform Computerized System Periodic Review - 10%
16. Manage and lead the periodic review program, coordinate reviews, and develop reports.
17. Context of the Job/Major Challenges
18. Develop validation strategies, prioritize resources, evaluate risks, and support regulatory inspections.
19. Dimensions/Scope
20. Responsible for site validation, working in both office and manufacturing environments, with occasional travel.
21. Requirements
22. Bachelor's degree in engineering or science, 5+ years of relevant experience in biopharmaceutical manufacturing, and knowledge of validation and industry standards.
23. Preferred qualifications include computer skills, scientific writing, team management, and strategic planning experience.
24. Why Choose Us?
25. Opportunity to contribute to life-changing healthcare solutions, grow your career, and enjoy comprehensive benefits.