Job Description

Sanofi Manufacturing & Supply is preparing its future through an ambitious program named Modulus. The Modulus Project is at the cornerstone of Sanofi’s strategy, aiming to create a new generation of evolutive multi-product facilities that are modular, adaptable, and agile, while leveraging disruptive technologies to better address vaccine and biologics manufacturing challenges.

The Utilities & Maintenance Engineer is responsible for supporting the operation, maintenance, reliability, and continuous improvement of clean utilities, black utilities, and single-use manufacturing equipment within the Modulus Singapore facility. The role ensures systems operate safely, efficiently, and in compliance with cGMP, regulatory, and HSE requirements to support uninterrupted manufacturing operations.

Key Responsibilities

Utility & Process Equipment Operations and Maintenance

• Perform routine preventive and corrective maintenance activities on clean and black utility systems and single-use process equipment.
• Support operation and maintenance activities for systems including chilled water, compressed air, steam, water systems, RO water, WFI, clean gases, solvent systems, and waste management systems.
• Maintain and troubleshoot single-use manufacturing equipment such as bioreactors, UFDF systems, biosafety cabinets, centrifuges, autoclaves, washers, dispensing booths, and column packing systems.
• Possess working knowledge of valve maintenance and repair, including PSV, GEMU, control valves, pinch valves, butterfly valves, and check valves.
• Ensure all maintenance and operational activities are properly documented in compliance with cGMP and regulatory requirements.
• Support production teams in troubleshooting equipment and utility-related issues while identifying escalation requirements where necessary.

Reliability & Maintenance Excellence

• Develop and implement reliability strategies to improve system performance, equipment uptime, and operational efficiency.
• Support and execute preventive maintenance programs to minimize system failures and unplanned downtime.
• Conduct routine inspections, operational audits, and regulatory compliance reviews for utility and process systems.
• Ensure contractors, vendors, and suppliers are provided with appropriate technical direction, with strong emphasis on safety, reliability, and GMP/GDP compliance.
• Support workload, schedule, and cost management activities within approved maintenance budgets.
• Participate in startup support activities, operator familiarization, and on-site training initiatives.

Start-Up, Commissioning & Qualification Support

• Support commissioning and qualification activities for utility and process systems in an operating GMP environment.
• Participate in startup, system shakedown, pre-startup checks, and commissioning activities.
• Support activities related to HAZOP, HAZID, FMEA, SOP development, CMMS setup, and maintenance procedure implementation.
• Review and update operational support documentation including SOPs, preventive maintenance plans, and training matrices.

Cross-Functional Collaboration & Compliance

• Support investigations, root cause analysis, deviation investigations, and CAPA implementation related to equipment and utility failures.
• Ensure compliance with Sanofi Safety Programs, HSE regulations, and OSHA requirements.
• Coordinate with manufacturing and maintenance planning teams to establish maintenance schedules without impacting production activities.
• Collaborate closely with engineering, production, quality assurance, and regulatory teams to support operational objectives and continuous improvement initiatives.
• Participate in interdisciplinary projects to optimize reliability, operational efficiency, and manufacturing performance.

Contractor & Team Coordination

• Oversee contractors and vendors to ensure safe and effective execution of maintenance and support activities.
• Support coaching and training initiatives to improve technical competencies and professional development within the maintenance team.
• Promote strong teamwork, collaboration, and compliance culture across all operational activities.

Core Competencies

• Strong understanding of utility systems, single-use manufacturing equipment, and maintenance best practices within GMP-regulated environments.
• Strong troubleshooting, analytical, and problem-solving capabilities.
• Knowledge of regulatory expectations including FDA, EMA, HSA, cGMP, and GDP requirements.
• Good understanding of reliability engineering and preventive maintenance concepts.
• Strong communication and stakeholder management skills.
• Ability to coordinate contractors, vendors, and cross-functional teams effectively.
• Good project ownership, planning, scheduling, and reporting capabilities.
• Strong commitment to safety, quality, compliance, and continuous improvement.

Technical & Educational Background

• ITE/Diploma in Mechanical or Electrical Engineering from an accredited technical institution.
• Minimum 5–8 years of relevant experience in utility systems and single-use equipment operation and maintenance, preferably within pharmaceutical, biologics, or biotechnology manufacturing environments.
• Experience supporting clean and black utility systems in GMP manufacturing facilities is highly preferred.
• Experience in vaccine manufacturing environments would be advantageous.
• Boiler Competency certification would be an added advantage.
• Familiarity with SAP CMMS systems is advantageous.

Job Expectations

• Based in Tuas South, Singapore.
• Role requires 12-hour day/night shift rotation.
• May require operational standby support for critical system or equipment breakdowns.

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