Business System Owner

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

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Our Team:

Our mission is to improve manufacturing performance every day on all aspects, with priority on Safety, Quality & Compliance, and Supply. We combine Operational Excellence and Smart Factory technologies to create a connected, data-driven, and continuously improving operation. Through SMS and lean principles, digital tools, connected equipment, real-time insights, we help teams eliminate waste, solve problems faster, and deliver right-first-time quality, on time and in full. We empower employees to make better decisions through greater visibility, standardization, and automation. Together, we build a safer, smarter, and more reliable manufacturing site that consistently deliver on supply commitments to patient.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

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

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.

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 toidentify 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 concernregardingyour personal information. You can also contact Canada’s Privacy Officer via Sanofi’s datasubject request portal, can also be used to request access or correction of your personal information and file a complaint.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.