Production System Engineer

Reference No. R2760937

Position Title: Production System Engineer

Department: FFILP Project​

Location: Toronto, ON

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

The B53/B83 FFILP (Formulation, Filling, Inspection, Label and Packaging) Production System Engineer is a key role within the B53/B83 FFILP manufacturing team. To be successful in this role the system engineer shall have a proven track record of being an independent thinker, problem-solver and a team leader/player. The system engineer shall also have a profile which includes the ability to troubleshoot/diagnose technical issues, train staff, and identify and implement effective technical recommendations. This role will work closely with multi-functional teams such as but not limited to Automation, Technical services, Manufacturing Technology, Quality, external vendor and HSE.

The incumbent is also responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with industry and Sanofi guidelines, within budget and schedule commitments.

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Main Responsibilities:

Summary

• Extensive knowledge in various automation /digital platforms in production (MES, DeltaV, PLC, etc.)

  • Process troubleshooting – recognize alarms and help diagnose complex issues; first responder on the production floor to complex issues.

  • Process / Automation SME to help translate issues for automation and IMS team to support.

  • Stakeholder in all future improvement projects to define URS to incorporate process and automation requirement.

  • Key decision maker in approach to problem solving/troubleshooting linked to batch implications, subsequent cost implications.

Detailed

• Troubleshoot/diagnose complex technical issues within the FFILP production area.

  • Directly support operations with troubleshooting and issue resolution with respect to, equipment, process, automation, facility and HSE disciplines.

  • Review and provide guidance on complex deviations prepared by technical staff.

  • Technical engineering support to process area. Apply lessons learned from other areas/sites to help with trouble shooting, design issues and testing specifics. Responsible to understand site specific and global standards and procedures.

  • In collaboration with platform management and other stakeholders, participate in developing appropriate technical CAPAs with a clearly defined scope to address the root cause of complex deviations.

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• Lead technical FFILP process improvement strategies,

  • Perform engineering analysis to reduce downtime and cost.

  • Evaluate and analyze current production activities and make process improvement recommendations.

  • Develop process improvements strategies to effectively utilize equipment and materials.

  • Develop operational strategies to achieve production and financial objectives.

  • Manage or support technical projects and staff in FFILP such as but not limited to replacement of equipment, facility upgrades, system upgrades and liase with the Technical Services/Engineering departments.

  • Key lead of project development and execution in FFILP including mechanical completion and start-up. Participate in FAT, SAT and Critical Test plan execution and operations turnover, operations execution.

  • Review process flow diagrams, mass balances and process descriptions including critical parameters provided by Manufacturing technology. Determine thoroughness to proceed with engineering design. Responsible to understand the process requirements and how they impact the equipment design.

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.

Context of the job/Major challenges:

• Collaborate with multi-functional teams (Formulation, Filling, Inspection, Label and Packaging) to resolve technical issue and provide effective technical solutions/recommendations in a GMP environment – both in the context of short-term troubleshooting and medium to long term strategy.

Dimensions/Scope:

• Oversight of activities in B53/B83 FFILP including 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 spaces (Obeya, Miro, Excel, Word, Teams) in a large and complex project environment where quick critical thinking and decision making is required.

• Technical aptitude/understanding across a broad number of subjects including but not limited to 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.

• Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.

• Working knowledge of unit operations typically used in biotech and vaccine manufacturing such as Upstream, Downstream, Adsorption, MBWS, Formulation, sterilization in place (SIP) and cleaning in place (CIP).

• Project Management skills to ensure project meets budget/timeline.

Education/Certifications:

• Minimum Bachelor’s degree in Engineering (such as Electrical, Automation, Chemical, Bioengineering) or Biotechnology or related science.

Experience:

• 5 + years of experience in vaccine manufacturing / large project experience are preferred.

Competencies:

• Strive for results

• Cooperate transversally

• Act for change

• Commit to customers

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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