Purpose

Vaccines M&S is preparing its future through an ambitious program named Evolutive Facility (EVF). The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.      

As a Utility Engineer to take up Utility and HVAC systems from Mechanical completion phase and ensuring the efficient and reliable operation of utility systems essential for the manufacturing process. Your responsibilities encompass the testing, commissioning, qualification, Operation and maintenance of various utility and HVAC systems critical for the production and distribution of vaccines. This role demands a strong understanding of engineering principles, particularly in the realm of utilities within pharmaceutical manufacturing environments.

The Utility engineer will report to Maintenance EFU Manager.

Key Areas:

Operation and Maintenance of utility systems:

• SME for operation and maintenance of Clean and Black utility systems, and infrastructure services. (Chilled water system, Compressed Air system, Water systems, Steam system, Waste management, RO water, Water for injection, Clean gases and solvent systems)
• Coordinate and supervise the operation team to operate all the utility system by 24 X 7 continuous system operation to support plant activities without any interruption.
• Lead for all the trouble shooting of Utility and facility systems.
• Ensure all operation and maintenance activities are meticulously documented to demonstrate compliance with regulatory requirements.

Operation and Maintenance of HVAC systems:

• SME for operation and maintenance of HVAC systems, and infrastructure services. (AHU, FCU, Cold-room, DX units, Dehumidifiers)
• Lead for all the trouble shooting of HVAC systems.
• In charge for all the clean room operation and testing.
• Ensure all operation and maintenance activities are meticulously documented to demonstrate compliance with regulatory requirements.

People Management:

• To oversee and manage the utility team/Technicians.
• Manage 24X7 hrs. Utility and HVAC operation with Utility team.
• Prepare and provide coaching/Training to utility team to improve personal and professional career development.

Reliability:

• Develop and implement reliability strategies to ensure performance and operation efficiency of utility systems maintained well. Conduct routine inspections, troubleshoot issues, and coordinate repairs or upgrades as needed to minimize downtime and maximize efficiency.
• Support Plan and execute scheduled preventive maintenance activities to prevent failures.
• Routinely audit the operational performance and regulatory compliance of systems.
• Ensure all the contractors and vendor/suppliers given proper technical direction with an emphasis on safety, reliability and GMP/GDP.
• Perform work within budget and schedule parameters and provide appropriate feedback to manager for workload, schedule and cost management.
• Perform and/or facilitate on-site startup and training activities.

Start-Up and C&Q management for Utility and HVAC system:

• Lead commissioning and Qualification of utility and HVAC systems, working closely with contractors, vendors, and internal stake holders to ensure systems are installed correctly and function as intended.
• Support and participate in commissioning & qualification of related systems in an operating plant, including related HAZOP, HAZID, FMEA, SOP, CMMS, maintenance procedures and regulation requirements. 
• Support to prepare the C&Q related documents like URS, DR, FCCA, SIA.
• Participate in system startup, shake down, pre startup check and commissioning of the engineering and process systems.
• Review and update the operation support documents like SOP, PM plan, Training matrix.

Cross-functional Collaboration:

• Lead investigations and root cause analysis of repetitive problems and investigate equipment failures as part of deviation investigation and CAPA.
• Ensuring assigned CAPA/deviation/CCR/DCR tasks are managed and resolved in a timely manner.
• Utilize quality systems to ensure compliance with regulatory requirements.
• Comply with requirements from Sanofi Safety Program including Health and Safety regulations and OSHA requirements.
• Coordinate with manufacturing and maintenance planner to establish the detailed maintenance plan for the site with out impact on production schedule.
• Coordinating with statutory authorities for relevant approvals.
• Achieve financial objectives through efficient utility operation, cost improvement actions and optimal cost options.
• Work closely with other department disciplines, production teams, quality assurance, and regulatory affairs to support the overall objectives of the vaccine manufacturing project. Collaborate on interdisciplinary projects and initiatives to optimize operations and drive continuous improvement.

Pre-requisites:

Knowledge, Skills & Competencies / Language:

• Proficiency in engineering design software and tools, as well as familiarity with regulatory requirements such as FDA, EMA, HSA regulations and cGMP.
• Proficiency in maintenance and reliability systems, including design, installation, testing, and troubleshooting.
• Excellent verbal and written communication skills for interacting with internal teams, clients, and stakeholders.
• Strong analytical and problem-solving skills to diagnose complex technical issues and implement effective solutions.
• Familiarity with relevant industry codes, standards, and safety regulations
• Project ownership and decision-making skills
• Project scheduling & reporting skills
• Ability to lead contingent staffs, external resources, including vendors & contractors.
• Good team player willing to work for the common goal.

Qualifications / Requirement:

• Mechanical/Electrical Engineering Degree from an accredited technical institution.
• Minimum 8 years’ experience in Utility and Facility system operation and maintenance management, preferably with plant operations in engineering field, preferably with pharmaceutical manufacturing experience.
• Minimum of 3 years’ experience in supervisory and people management.
• Preferred with Singapore Certified Energy manager and Boiler Competence certification. Previous experience in utility engineering within the pharmaceutical or biotechnology industry, with specific experience in vaccine manufacturing highly desirable.
• Strong project management skills, with the ability to manage multiple priorities and deadlines effectively.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.
• Commitment to quality, safety, and compliance in all aspects of utility system operation and maintenance.

Any other requirements of the job :

• Familiarity with SAP computerized maintenance management systems is advantageous.
• Familiar with CAPEX project from BOD phase.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!