Clean Utilities Lead
PharmaBiotechMedTechRegulatory AffairsQuality Assurancegmpcroinform
Job description
Reference Number: R2872550 Position title: Clean Utilities Lead Location: Toronto, ON About the job 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. Engineering & Maintenance (E&M) plays a critical role in keeping our site running safely, reliably, and compliantly. From capital projects to hands‑on equipment reliability, our work enables uninterrupted production every day. Within E&M, the Clean Utilities & Sustainability division ensures a dependable and sustainable supply of electricity, steam, water, and other critical utilities, supporting both operational excellence and Sanofi’s Planet Care ambitions. 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: Ensure safe, reliable, efficient critical water systems (including pre-treatment, Reverse Osmosis (RO), Water For Injection (WFI)) and clean steam Lead investigations and develop Corrective and Preventative Actions (CAPA) for unplanned utility disruptions or Environmental Monitoring (EM) excursions Identify energy/water efficiency improvement opportunities for critical systems Act as key Subject Matter Expert (SME) for critical utility systems for any quality related discussions including during audits/inspections Coordinate periodic outages for shutdowns, passivation, maintenance, and calibration Participate in applicable Community of Practice (CoP) Lead the unionized critical utilities department team to ensure sampling, daily checks, maintenance, and other tasks are followed. Ensure team is fully integrated with other functions in the E&M department and Quality department to ensure quality compliance, to support site operation in 24/7 schedule. Initiate, review and approve technical documents for clean utilities. (Standard Operating Procedures (SOP), Change Control Requests (CCR), deviations and Corrective and Preventative Actions (CAPAs)). Drive capital investment in systems by submitting project requests as needed for improving performance or reducing cost for other groups in management of systems. Perform gap assessments on utility SOPs including operating, validation, and routine monitoring to ensure compliance to corporate standards. Work with Engineering team to assist in different phases of projects for utility and biowaste systems. Ensure technical review from User Requirement Specifications (URS), Piping & Instrumentation Diagrams (P&ID), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols are properly prepared and are aligned with compliance requirement, current SOPs, maintenance standards and current best practices. 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. About you Bachelor’s degree; preferably with a concentration in Electrical/Mechanical or Chemical Engineering Minimum 5 years of experience within a GMP-regulated pharmaceutical, biologics, medical device, API or life sciences manufacturing environment ideally as an Engineer with a strong preference towards supporting clean and black utility systems Minimum 2 years of experience working maintenance engineering in pharmaceutical/biopharma industry preferred Strong people skills with experience in managing projects/teams with demonstrated ability to pro-actively work with cross functional groups within the organization preferably in a unionized environment. Strong people skills with experience in managing unionized team with demonstrated ability to pro-actively work with cross functional teams In-depth understanding of GMP clean utility systems and related regulatory compliance requirement Understand SMS tools and help drive and implement new ways of working Fundamental understanding of industrial production environment and maintenance & engineering practices Require high level of critical thinking and prioritization. Experience in audit preparation and participation in internal and external audits a plus 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 current vacant role that we are actively hiring for. 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 <a target="_blank" href="https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fprivacyportal-eu.onetrust.com%2Fwebform%2Fdd85e611-5592-4331-b346-b8739f63f687%2Fa02f5bbc-d820-431e-8549-50e9994da67b&data=05%7C02%7CJeff.Cabador%40sanofi.c
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