MES & Digital Manufacturing System Lead

BioTalent Canada; Toronto; On-site; CAD 90,000 - 130,000; Full time

Benefits offered by this job

Health and wellbeing benefits

Competitive rewards package

Career growth and international chance

Job summary

Sanofi is seeking a CSA/BSO-level expert to own MES and Opstrakker at the Toronto site, ensuring system readiness, governance, and alignment with GMP, CSV, and 21 CFR Part 11 regulations. You will drive standardization, collaborate with Digital and Quality teams, and champion shop-floor improvements.

The role emphasizes cross‑functional leadership, system evolution, and adherence to data integrity, with opportunities to influence roadmap and harmonize core model adherence across functions.

Qualifications

• Bachelor’s degree in Science, Engineering, Computer Science or equivalent technical discipline.
• Minimum 3+ years in pharmaceutical or biopharmaceutical manufacturing operations.
• Hands‑on experience with MES platforms and shop‑floor performance/ OEE solutions.

Responsibilities

• Own the MES and Opstrakker systems at the Toronto site, influencing roadmap and validation status.
• Serve as the primary business point of contact for MES and Opstrakker at the Toronto site.
• Ensure proper usage and governance, supporting end users and standardization.
• Represent the Toronto site in design authorities and contribute use cases.

Skills

MES systems

OEE awareness

Cross-functional collaboration

Quality & Compliance

Education

Bachelor’s degree in Science/Engineering/CS

Tools

Werum PAS‑X

Rockwell

CSV IQ/OQ/PQ

Job description

Sanofi is seeking a CSA/BSO-level expert to own MES and Opstrakker at the Toronto site, ensuring system readiness, governance, and alignment with GMP, CSV, and 21 CFR Part 11 regulations. You will drive standardization, collaborate with Digital and Quality teams, and champion shop-floor improvements.

The role emphasizes cross‑functional leadership, system evolution, and adherence to data integrity, with opportunities to influence roadmap and harmonize core model adherence across functions.