Job Description

Reference No. R2720259

Position Title: Water system senior Technologist

Duration: Fixed-Term - Contract, End Date: December 27, 2024

Department: Critical Utilities & Support

Location: Toronto, Ontario

Sanofi Vaccines

Sanofi\'s global vaccines business unit partners with the public health, medical and scientific communities to improve access to life-protecting vaccines and increase vaccination coverage, while striving to develop new and improved vaccines to enhance health and well-being.

At Sanofi, we chase the miracles of science to improve people\xe2\x80\x99s lives. We believe our cutting-edge science and manufacturing, fueled by data and digital technologies, have the potential to transform the practice of medicine, turning the impossible into possible for millions of people.

Major Activities of the Job:

Operate and maintain critical utilities including but not limited to purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems in accordance with established SOPs and SWIs in a professional and timely fashion and initiate any required repairs and rechecks. Actively operate and troubleshoot the Delta V operating systems for critical utility systems in accordance with critical utility system SOPs.

Troubleshooting and repair of each buildings critical utilities systems and equipment specific to purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems. Ensure 24 hours/7 days, uninterrupted, continuous operation of PW, WFI and CS generation, storage and distribution systems.

Coordinates and works with other trades, engineering, contractors and stores to ensure maintenance work is completed in a timely fashion.

Perform repairs where a specialized license is not required. Examples include diaphragms, tri-clamps, hoses, pumps, filters, membranes and gaskets replacements.

Use P&IDs and manuals as required for troubleshooting.

Provide update on issues to manager, quality (QOSA or Shop Floor) and internal customers as required and timely release of the critical utility systems during PM shutdowns.

Execute or follow-up on reactive, preventative, and predictive maintenance tasks as assigned on cGMP critical utilities in accordance with established effective SOPs. Supervise contractors performing PM tasks on cGMP critical utilities.

Carry out preventative and predictive maintenance tasks based on established daily, weekly, monthly, annual frequencies using SAP work order system where not restricted by regulatory licensing requirements.

Prepare and initiate utility assessment documentation for all critical utility shutdowns and restarts.

Identify, request and register parts when required to perform reactive or routine maintenance.

Ensure proper equipment lock out and tag out procedures are executed as required. Administer the release of critical utilities for production use (i.e timely review of all applicable data to ensure compliance to established standards and requirements).

Supervise contractors performing maintenance tasks on the critical utilities such as passivation, calibration, etc.

Monitor mechanical rooms for cleanliness and any other abnormal conditions such as leaks, and carryout repairs as required.

Determines impact of required work, communicates, co-ordinates and perform major PM cGMP tasks such as RO/CDI maintenance, critical utility cleaning / passivation / steam sanitization maintenance tasks. Routine quality monitoring of PW Generation and Distribution Systems, WFI Generation and Distribution Systems and Clean Steam Generation and Distribution System.

Coordinate major PM tasks / shutdown work on critical utilities with planning, internal customer, trades and contractors to minimize service interruption.

Review major planned shutdown work orders with planner using the SAP system. Co-ordinates with stores to ensure all necessary parts such as vent filters, RO

Membranes, Continuous Deionization stacks, rupture discs, UV lights, filters, etc. are available. Maintain and replace caustic and basophile chemicals, oil and salt levels.

Monitors the condition of the metallic-product contact surfaces of the purified water, clean steam and water for injection generation, storage and distribution through trace metal analysis and visual inspection. Proactively initiates remediation through passivation of the systems and the corresponding steam sanitization of the critical utility systems.

Arranges for shutdown work in coordination with planner and building managers. Performs vent filters, RO membranes, rupture discs, UV lights/sleeves, filters, CDI stacks replacement.

Daily verification and logging of critical operational process measurement and control instrumentation parameters via approved log sheets. Recommend appropriate alert/action limits for routine monitoring.

Perform utility data analysis. Review all relevant data on regular basis and recommend corrective/preventive actions and applicable product disposition.

Make running adjustments to equipment within validated operational parameters.

Monitor FMS / BAS / DMS/ PI / Delta V system for proper operation of critical utilities such as purified water (PW), clean steam (CS), water for injection (WFI) generation, storage and distribution systems. Respond or identify all cGMP and business critical alarms within the required time frame. Provide support for trouble shooting issues, addressing related N/Cs and / or CAPA / CCR related documents.

Monitor FMS / BAS / DMS/ PI / Delta V systems for proper operation of equipment / systems.

Respond to alarms and carry out necessary troubleshooting / repairs to resolve alarm conditions. Coordinate with other trades, engineering and contractors if needed to resolve any alarm issues.

Inform the manager, quality (QOSA and/or Shop Floor) and internal customer of the troubleshooting, corrective and preventative actions taken / needed to correct alarm conditions.

Update alarm tag notes in the system. Document information in the work order system. Initiating and leading CAPAs and CCRs. Support gap and/or process improvement assessment. Collect relevant data for investigation and analysis. Present findings and follow up on remedial/improvement actions.

Participate, coordinate and provide support during audit and internal/external inspection.

Prepare inspection readiness of the critical utility systems in a timely manner. Defend the critical utility systems monitoring program during internal and external inspection when required.

Operate critical utilities such as purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems in accordance with established SOPs and SWIs.

Operate critical utilities such as purified water (PW), clean steam (CS) and water for injection (WFI) generation, storage and distribution systems in accordance with established SOPs and SWIs

Troubleshoot and maintain critical utilities and associated systems. Document and log critical utility equipment and system conditions.

Inform the manager, quality (QOSA and/or Shop Floor) and internal customer of the troubleshooting, corrective and preventative actions taken / needed to correct alarm conditions.

Any other duties and responsibilities as assigned such as commissioning, qualification, and validation of new critical utility systems, training new water systems technologists / contractors, authoring and updating all operational critical utility SOPs, managing or leading relevant CAPAs & CCRs, assist on deviations / safety investigations, initiating work orders.

Other activities as requested which may include Continuous Improvement projects, initiatives or tasks. Develop and/or review critical utility systems related specifications, SOPs and SWIs.

Train new water system technologists as required.

Write and execute supplements for commissioning, qualification, and validation of new critical utility systems. Participate in design reviews and assist in writing new SOPs and PM Plans for new systems.

Other duties as assigned to operate the business.

Minimum Qualifications:

Minimum three (3) years College Diploma (Controls, Instrumental, Mechanical Engineering, Mathematics, Science, Biology, Chemistry, Physics), plus a minimum of three (3) years of previous relevant work experience.

Preferred four (4) years bachelor\xe2\x80\x99s degree (Controls, Instrumental, Mechanical and Process Engineering), plus a minimum of three (3) years of previous relevant work experience.

Other recognized formal education 1 week to 3 years of \xc3\x8cSA, PDA Pharma certificate or Credit Programs (Hydraulic, Electrical / Electronic, Pneumatic Measurement & Control Principles, PLC, SCADA, DCS programming, Pharmaceutical / Life Science Courses).

Strong knowledge of Process management and controls.

Strong knowledge of Blueprint reading and Red Lining And Technical Writing & Documentation.

Microbiology, DI/RO /continuous Electronic Deionization.

Hours Of Work:

Inclusive from Monday to Friday: 8:00 A.M \xe2\x80\x93 4:00 P.M.

Pursue Progress.

Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn\xe2\x80\x99t happen without people \xe2\x80\x93 people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let\xe2\x80\x99s be those people.

Watch our and check out our Diversity, Equity and Inclusion actions at !

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.

Thank you in advance for your interest.

Only those candidates selected for interviews will be contacted.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Sanofi