Job Title: Validation Engineer II

Location:
Toronto (North York), Canada Type: Contract Term: 12-months Schedule: Hybrid (3 days on-site); Monday
- Friday; 8 AM
- 4 PM ET Pay Rate Max: $60 CAD per hour Sanofi's contingent workforce program, FLEXT Direct, is seeking a Validation Engineer II for a 12-month contract. This role offers a unique prospect to drive end-to-end project delivery, lead technical and scientific initiatives, and collaborate with diverse cross-functional teams to advance vaccine manufacturing excellence. The ideal candidate will bring strong process knowledge, structured problem-solving capabilities, and a passion for continuous improvement within a highly regulated biopharmaceutical environment. Responsibilities
• Support end-to-end project delivery from business case development through planning, execution, regulatory submissions, and closure, ensuring on-time and on-budget outcomes aligned with established Project and Program Management principles
• Support the design and implementation of new technologies and process improvements, including technology transfers, and lead technical topics related to development and validation strategies and studies
• Collaborate with Production, Quality, Technical Services, Regulatory Affairs, R&D;, and other local and global functions to advance process improvements, new technology adoption, validation activities, and regulatory submissions
• Develop and manage project plans, budgets, and performance reporting while identifying risks and mitigation strategies and seeking opportunities to improve process efficiency, productivity, throughput, and cost reduction
• Support technical resolution of manufacturing issues using structured troubleshooting, process knowledge, and root cause analysis to determine potential product impact
• Support the team in change control and corrective action and preventative action processes,



leading changes and supporting technical studies required for CAPAs to ensure timely delivery
• Support licensed products through ongoing process optimization and daily production support, leveraging deep process knowledge to achieve industrial excellence
• Lead or participate on project teams as the Manufacturing Science and Technology representative, interfacing with Manufacturing, QC, QA, Regulatory Affairs, and R&D; to provide product and process technical expertise Skills
• Strong technical knowledge of vaccine formulation processes and manufacturing operations
• Proficiency in structured troubleshooting, root cause analysis, and investigation methodologies
• Experience with change control, CAPA, and quality management systems in a regulated environment
• Solid understanding of validation strategies, technology transfer, and regulatory submission requirements
• Demonstrated ability to manage multiple projects simultaneously with competing priorities and deadlines
• Excellent cross-functional collaboration and communication skills across scientific, operational, and regulatory teams
• Strong analytical and problem-solving capabilities with a continuous improvement mindset
• Ability to develop and manage project budgets, timelines, and risk mitigation plans
• Familiarity with GMP regulations and compliance requirements within the biopharmaceutical industry Qualifications
• Bachelor's degree or higher in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline
• Advanced degree (M.
S. or Ph.
D.) preferred and may be considered in lieu of experience requirements
• Minimum 3 years of prior working experience in vaccine or biologics manufacturing, formulation, or process development within a GMP environment
• Demonstrated experience supporting or leading process improvement and technology transfer projects
• Experience working within cross-functional teams including Quality, Regulatory Affairs, and R&D;
• Background in CAPA management, change control processes, and manufacturing investigations

📌 Validation Engineer II (Toronto)
🏢 Sanofi
📍 Toronto