Validation Engineer II (Canada) (contract)
- Toronto, ON, Canada
Up to $60 CAD / hour · Contract
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Job details
- Pay
- Up to $60 CAD / hour
- Job type
- Contract
- Apply by
- Experience
- Minimum 3 years of prior working experience in vaccine or biologics manufacturing, formulation, or process development within a GMP environment
- Posting language
- English
- Posted
Original job description
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 opportunity 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
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 opportunity 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
- 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
- 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
More about this job
Responsibilities
Deliver manufacturing projects from business case through execution and closure, managing plans, budgets, risks, and performance. Lead or support validation, technology transfer, process improvement, manufacturing investigations, change control, CAPAs, and production support in collaboration with cross-functional teams.
Requirements
Requires a bachelor's degree or higher in a relevant scientific or engineering discipline and at least three years of experience in vaccine or biologics manufacturing, formulation, or process development in a GMP environment. Candidates should have experience with process improvement or technology transfer, cross-functional work, CAPA, change control, and manufacturing investigations; an advanced degree is preferred and may substitute for experience requirements.
Skills
- Vaccine Formulation
- Biologics Manufacturing
- Structured Troubleshooting
- Root Cause Analysis
- Change Control
- CAPA Management
- Quality Management Systems
- Validation Strategies
- Technology Transfer
- Regulatory Submissions
- Project Management
- Budget Management
- Risk Mitigation
- GMP Compliance
- Cross-Functional Collaboration
- Continuous Improvement
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Manufacturing
- Science & Research
- Management & Leadership
Keywords
- Vaccine Manufacturing
- Biologics Manufacturing
- Vaccine Formulation
- GMP
- Validation
- Validation Strategies
- Technology Transfer
- Process Development
- Process Improvement
- Project Management
- Project Plans
- Project Budgets
- Risk Mitigation
- Structured Troubleshooting
- Root Cause Analysis
- Manufacturing Investigations
- Change Control
- CAPA
- Quality Management Systems
- Regulatory Submissions
- Regulatory Affairs
- Production Support
- Process Optimization
- Continuous Improvement
- Cross-Functional Teams
- Manufacturing Science and Technology
- Quality Control
- Quality Assurance
- Product Impact Assessment
- Industrial Excellence