Process Validation Specialist

Process Validation Specialist

Location : North York

Division : Vaccine Manufacturing

This is an exciting opportunity to play a pivotal role in the launch of a newly built production facility for flu vaccine manufacturing. As part of the project team, you will contribute to validating the manufacturing processes necessary to meet regulatory standards and deliver consistent, high-quality vaccines.

Position Overview

The Process Validation Specialist will support and execute process validation activities, including engineering, development, and PPQ (Process Performance Qualification) study runs. This role is critical to demonstrating that the flu vaccine manufacturing process can be performed consistently while meeting regulatory and process requirements.

As a key member of the team, the Process Validation Specialist will collaborate with cross-functional stakeholders, including production operators, quality representatives, maintenance teams, and engineering personnel, to ensure seamless validation activities in the upstream, downstream, and support areas.

Key Responsibilities

• Execution of Process Validation Activities :
• Execute process validation runs, including engineering, development, and PPQ study runs.
• Monitor prerequisites and escalate risks to the execution plan during validation phases.
• Coordinate validation activities across upstream, downstream, and support areas.
• Documentation & Reporting :
• Author detailed technical documents such as protocols, validation reports, root cause analyses, and risk assessments using client's documentation management system.
• Analyze raw data and provide insights to ensure compliance with regulatory and process requirements.
• Cross-functional Collaboration :
• Provide technical guidance and direction to production operators, quality teams, and maintenance personnel during validation activities.
• Work closely with operations, engineering, and quality teams during validation, start-up, and ramp-up phases.
• Issue Management :
• Identify non-conformances, draft impact assessments, and recommend corrective actions.
• Ensure timely resolution of process-related issues to minimize delays.

Qualifications & Experience

Must-Haves :

Nice-to-Haves :

Why Join Us?

ALTEN Canada fosters a dynamic and collaborative work environment where team members are

empowered to unleash their full potential. We believe in investing in our talent, offering stimulating experiences, and supporting professional growth and development at every turn.

As part of our commitment to our team members, we offer a comprehensive benefits package including :

Join ALTEN Canada and embark on a journey of endless possibilities, where your talents are

celebrated, and your ambitions are nurtured. Experience the difference of working with a company

that values innovation, collaboration, and excellence in every endeavor.