Production System Engineer- Vaccines
多伦多, 加拿大 Fixed Term 发布日期 Nov. 18, 2024Reference No. R2762085
Position Title: Production System Engineer- Vaccines
Department: B200 Operations – Downstream
Location: Toronto, Ontario
Fixed Term Contract: Approximately 18 months to June 2026.
About the Job:
The Production System Engineer is a key role within the New Flu Building (B200) manufacturing team. To be successful as a Production System Engineer, you should be an independent thinker, keen problem-solver and a team leader/player. You should be able to diagnose technical issues, and provide and implement effective technical solutions. This position will coordinate and be responsible for interfacing with different functions : Digital, Maintenance, Process Engineering, Operations, Manufacturing Technology, Quality and vendors.
The incumbent needs to be able to demonstrate and communicate good technical understanding of the automated systems and defend technical design decisions. The incumbent also needs to provide coaching and guidance to Operations team and other stakeholders including Quality to ensure key deliverables and timelines are met.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Diagnose problems in the production area (Downstream but can also support Upstream and Buffer area) and provide technical recommendations and training to support Operations to adherence to schedule. Directly support operations with troubleshooting and issue resolution with respect to automated systems and equipment issues.
Manage and lead technical projects in B200 such as replacement of equipment, building upgrades, system upgrades and assist the Engineering department.
Accountable for technical quality of design of systems. Perform appropriate reviews with vendors and stakeholders. Responsible for design that meets project budget and schedule for the applicable automation systems.
Develop process improvement strategies to effectively utilize equipment and materials. Determine impact on resources and budget, present strategy to stakeholders
Perform engineering analysis to reduce downtime and cost.
Review and provide guidance on deviations drafted by Operations staff.
Technical engineering support for process area; apply lessons learned from other buildings/sites to help with trouble shooting, design issues and testing specifics.
In collaboration with platform management and other stakeholders, develop appropriate technical CAPAs with a clearly defined scope to address the root cause of deviations.
Support the resolution of equipment and building issues.
Support required during Project phase runs only:
Supervision of night shift activities (~20 weeks in 2025)
After PPQ:
Lead implementation of changes/ day 2 projects
Act as Operations lead for new projects in B200 including mechanical completion and start-up. Participate in SAT and Test plan execution.
Review the C&Q test plans and support the commissioning and qualification tasks
Review process flow diagrams and process descriptions including critical parameters provided by Manufacturing Technology. Determine thoroughness to proceed with engineering design. Responsible for understanding the process requirements and how they impact the equipment design.
Prepare for Regulatory inspections by drafting investigation briefing packages / hot topics
HSE Requirement/Statement:
Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.
Identify unsafe operations and practices and report immediately.
Supervises and monitors compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures, and regulations applicable to their work.
Context of the job/Major challenges:
Collaborate with multi-functional teams (Automation, Technical services, Manufacturing Technology, Quality and HSE) to resolve technical issue and provide effective technical recommendations.
Dimensions/Scope:
Oversight of activities in B200 including execution of current project phase, new projects, troubleshooting, deviations and CAPAs
Financial dimensions: Impact on project delivery and cost
Human Resources dimensions: NA
Statistical dimensions: NA
Health & Safety dimensions: Oversight of safety compliance of process area.
About You
Requirements:
Ability to work in a collaborative shared space (Obeya) in a large and complex production environment where quick critical thinking and decision making is required.
Technical aptitude/understanding across a broad number of subjects including vaccine processes and equipment, HVAC systems, building and equipment maintenance.
Must understand the relationship between Good Manufacturing Practices, industry standards and their application to the manufacturing process.
Ability to effectively communicate with internal and external team members is essential.
Strong analytical skills (engineering analysis).
Familiar with computer systems validation practices.
Working knowledge of PLC’s and automation in DCS platform.
Experience authoring and reviewing standard operating procedures, validation protocols, and other controlled documents.
Working knowledge of unit operations typically used in biotech and vaccine manufacturing
Knowledge of clean utility design such as WFI, clean steam and clean air systems is desirable.
Management skills to ensure project meets budget/timeline.
Technical aptitude/understanding of digital system.
Core Competencies: Act for Change, Cooperate Transversally, Commit to Customers, Strive for Results, Think Strategically, Develop People, Make Decisions and Lead Teams.
Education Requirements:
Bachelor’s or Master's degree in Engineering (Chemical, Bioengineering, Process Automation) or Biotechnology.
5 + years of experience in vaccine manufacturing, sterile manufacturing, or biotechnology.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.
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