Position title: Business System Owner

Department: Smart Factory

Location: Toronto, ON

Main Responsibilities:

• Own the MES and Opstrakker systems locally at the Toronto site, ensuring fit for purpose, influencing product roadmap, integration with other core models (ishift, LIMS,DowntimeIQ, other digital tools) and maintenance of the validation status
• Serve as the primary business point of contact for MES and Opstrakker at the Toronto site
• Ensure proper usage of MES and Opstrakker, being gate keeper for maintaining and increasing standardization and adherence to evolving core models, and provide required support to shop-floor end users
• Participate to system evolution and innovation, by representing the Toronto site to the MES and Opstrakker design authorities, and raising appropriate use cases

Additional responsibilities:

Serve as the accountable business authority for requirements definition and validation across the MES and Opstrakker lifecycle. Ensure that business needs are accurately captured, correctly translated into functional specifications, and formally verified at each lifecycle gate; from initial URS authoring through change control and system evolution, n line with GMP, 21 CFR Part 11 and CSV (IQ/OQ/PQ) expectations

• Assess and provide business approval for change requests impacting system functionality, configuration, or integrations
• Manage user access governance and associated training requirements
• Coordinate periodic reviews and re-validation activities per site procedures
• Assess business impact of system incidents, deviations, and CAPAs
• Monitor and report system performance KPIs (availability, data integrity, adoption)
• Support Sanofi's digital transformation programs, specifically MES/eBMR (electronic batch records), Opstrakker, coordinating implementation activities and ensuring alignment across Manufacturing, Quality, Supply Chain and Digital.
• Coordinate with Business Process Owners (BPOs) in Manufacturing, Quality and Supply Chain to implement core model adherence and drive shop-floor process improvements.
• Ensure compliance with Sanofi standards, GMP, 21 CFR Part 11, data integrity (ALCOA+) and site procedures for computerized systems.
• System Evolution & Roadmap: Identify, assess, and prioritize MES and Opstrakker enhancements based on operational needs and value delivery, Build business cases for upgrades, new modules, or integrations (e.g., MES-SAP, MES-LIMS, Opstrakker-PiVision/DowntimeIQ), Co-develop system roadmap with Digital partners in alignment with Smart Factory strategy and the Sanofi Shine methodology, Support annual budget planning for the assigned system portfolio

About You

Qualification and Experience:

• Bachelor's degree in Science, Engineering (Chemical, Industrial, Manufacturing, Mechanical, or related field), Computer Science, Information Systems, or equivalent technical discipline
• Minimum 3+ years of experience in pharmaceutical or biopharmaceutical manufacturing operations or equivalent industries
• Hands-on experience with MES platforms (e.g., Werum PAS-X, Rockwell or equivalent) and shop-floor performance/OEE solutions (Opstrakker, or comparable)
• Working knowledge of GMP, 21 CFR Part 11, computer system validation (CSV IQ/OQ/PQ), electronic batch records (eBMR) and data integrity (ALCOA+)
• Proven project management experience, including leading cross-functional digital transformation initiatives

What Success Looks Like in This Role:

• MES and Opstrakker are inspection-ready at all times
• Change requests are processed with minimal disruption to batch execution and shop-floor operations
• System enhancements are prioritized against measurable operational outcomes (OEE, cycle time, RFT, COGS)
• Manufacturing, Quality, Supply Chain and Digital stakeholders view the BSO as a trusted, proactive partner

This position is for a new vacant role that is now open for applications.

AI Usage

"Artificial Intelligence" refers to any systems that use automated processes, including algorithms and machine learning, to analyze data and make predictions, inferences, decisions, or recommendations without direct human involvement. These systems may process personal information to identify patterns, improve services, or support decision-making. The Company may use Artificial Intelligence for purposes including, but not limited to, resume screening and hiring, scheduling interviews or meetings, conducting surveys, matching skills with potential job openings, interview scoring, ensuring compliance with regulations applicable to our industry, and activities related to performance evaluation. Information collected and processed by the Company's Artificial Intelligence systems may include the personal information detailed above and calendar availability. It excludes the information collected and processed for monitoring purposes. You should contact Human Resources if you have a question or concern regarding your personal information. You can also contact Canada's Privacy Officer via Sanofi's data subject request portal, Data Subject Rights Webform. The Data Subject Rights Webform can also be used to request access or correction of your personal information and file a complaint.

North America Applicants Only

The salary range for this position is:
83,800.00 - 133,100.00 (Includes target bonus)
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefits programs, and additional benefits information can be found through the (CA)LINKOR (US) LINK.

La fourchette salariale pour ce poste est la suivante:
83,800.00 - 133,100.00 (Comprend le bonus cible)
La rémunération finale sera déterminée en fonction de l'expérience démontrée, des compétences, du lieu de travail et d'autres facteurs pertinents. Les employés peuvent être admissibles à participer aux programmes d'avantages sociaux de l'entreprise, et des informations supplémentaires sur les avantages sociaux peuvent être trouvées via le lien