Job Description

Sanofi Pasteur: The world's leading vaccine company

Reference No: R2649072

Position Title: Maintenance Manager FFIP (Formulation, Filling, Inspection and Packaging)

Department: Sanofi Pasteur

Duration: Full-Time

Location: Toronto, ON

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

This role will initially focus on the Project deliverables as the Maintenance Manager listed below in the Key Accountabilities and transition into the ongoing Management for this facility. This is an exceptional opportunity for a motivated individual to setup and run your own facility right from the start. You will partner with your peers in Production, Reliability Engineering and Process engineering to setup the new facility / process for the site.

Directly supervise and co-ordinate maintenance work groups by providing on-going leadership and performance feedback to efficiently and effectively maintain the site's Infrastructure, Equipment, Systems and Building Services at a level that meets safety, regulatory compliance and/or applicable government guidelines and codes thus ensuring there is no loss of production or products.

KEY ACCOUNTABILITIES

Maintenance Manager for new FFIP project.

Collaborate with project and engineering teams to ensure project planning and execution of maintenance related tasks.

Participate and lead in the development / implementation of key documents (Project Plans, SOPs, Standards) by providing technical direction for the project on Maintenance activities.

Project Deliverables will include:

Review and approval of Drawings

Support Project team throughout validation process from Factory Acceptance (FAT) Installation Qualification (IQ) Operational Qualification (OQ) to Production Qualification (PQ)

Preventative Maintenance tasks / Calibration Plans / Service Agreements and spare parts are setup to ensure 100% uptime

Training Plans in Place for Maintenance Staff

Manage the setup and execution of the PM program on the black & clean utilities, refrigeration & HVAC units, infrastructure, building systems & equipment to meet regulatory requirements.

Supervise the trades personnel and the maintenance contractors to ensure the timely completion of assignments.

Ensures that the work completed complies with the "Best Maintenance Practices", HSE and Quality policies and procedures.

Review the work orders and close them in CMMS (SAP) once the maintenance work is completed and properly documented.

Communicate and collaboration with Production and Quality departments, ETS (Engineering Technical Services) team consisting of Reliability Engineering, Planning and Scheduling, Process Engineering, Automation, Metrology and service contractors with regards to equipment and systems to support production schedule and reduce downtime.

Activities will include investigations of process/equipment deviations to determine root cause and corrective actions.

Work closely with the APU Lead and Cost Control team to establish annual departmental operating budget; maintains and controls spending according to budget and provides explanation for variances; minimizes product lost.

Provide recommendations or support for cost savings initiatives as appropriate.

HSE REQUIREMENT/STATEMENT

Ensure safety of personnel and compliance with environmental, safety and health procedures relating to facility operations.

Supervise and monitor compliance with employment and health and safety legislation to ensure that employees work within the policies, procedures and regulations applicable to their work.

Participate in the investigation of incidents and work-related illnesses.

Respond promptly to all health and safety concerns or incidents and completes the

appropriate documentation in a timely manner.

Take every reasonable precaution to ensure the health and safety of staff.

Ensure that protective equipment and clothing required is used by staff (internal or external).

Cooperate and assist the Joint Health and Safety Committee in carrying out its functions.

Advise staff of any potential or actual health and safety hazard of which they are aware.

CONTEXT OF THE JOB/MAJOR CHALLENGES

Must have an understanding of related trades (i.e. Mechanical, Electrical, Refrigeration, Building Services, BMS etc.), equipment and systems and the various areas within the facility, from the biotechnical production areas to the related support functions within the mechanical rooms.

Display good knowledge of cGMP Guidelines/Policies and compliance requirements, ability to prepare and monitor their maintenance budget and ability to manage individuals.

Decisions made by the Maintenance manager have the potential to impact the business by interrupting GMP manufacturing processes and cause significant financial losses.

During maintenance activities, Product SISPQ (Safety, Integrity, Strength, Purity and Quality) should always be the most important consideration.

REQUIREMENTS

Education/Certifications:

Minimum 5 (five) years, direct experience in pharma / biotech manufacturing and quality environments/organizations

Minimum 5 (five) years demonstrated leadership in behavioral competencies.

Licensed Professional Engineer (Ontario) or Membership in Professional Association(s) related to this field (i.e.OACETT) preferred

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Experience:

The individual should have worked with Maintenance personnel for at least 5 years in a supervisory position with increased levels of responsibility and have a good understanding of

all trades, current maintenance best practices, GMP/GLP and common issues addressed by Maintenance.

Process and Project engineering experience is desired. Experience leading and managing new product/process projects of $1-5M is considered an asset.

Document/Process Change Control and CAPA Management System experience is desired.

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.

Sanofi, Empowering Life

#GD-SP

#LI-SP

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.