Reliability & Methods Specialist

Overview

Sanofi is advancing its future with the Modulus program, focusing on creating cutting-edge, adaptable multi-product manufacturing facilities at its Singapore site in Tuas. This initiative integrates advanced technologies to strategically enhance business operations in Pharmaceutical Manufacturing & Supply.

Role Purpose

The Reliability and Methods Specialist plays a pivotal role in enhancing the reliability, sustainability, and maintainability of both GMP and non-GMP systems on site. This involves delivering engineering design insights, maintenance support, assisting new system installations, driving continuous improvements, and resolving issues in existing equipment. The role reports directly to the Head of Maintenance & Reliability.

Key Responsibilities

• Develop and upkeep FMECA documentation for risk assessment, reliability initiatives, and crafting maintenance strategies tailored to the plant.
• Conduct regular analyses on equipment data to identify improvements, elevate uptime, and minimize ownership costs.
• Administer methods to analyze reliability for components, equipment, and processes.
• Oversee predictive maintenance programs including vibration analysis, infrared thermography, motor circuit analysis, and ultrasonics.
• Interpret predictive maintenance outputs to prioritize necessary corrective measures.
• Ensure proper documentation of maintenance tasks to meet regulatory standards such as cGMP.
• Support management of contracts and changes related to maintenance and engineering projects.
• Assist with scheduling and executing preventative maintenance to reduce failures and boost equipment reliability.
• Manage CAPA, deviation, CCR, and DCR assignments to ensure timely resolution.
• Lead projects focused on improving or replacing frequently problematic equipment.
• Investigate root causes of recurring faults and equipment failures, contributing to deviation and CAPA efforts.
• Assist in audits concerning maintenance and equipment compliance.
• Contribute to commissioning and qualification processes for operational plant systems.
• Participate in safety and compliance activities including HAZOP, HAZID, FMEA, SOP development, CMMS use, and regulatory adherence.
• Engage in start-up activities including system shakedown, pre-startup verifications, and commissioning for engineering and process equipment.
• Review and refresh operational documents such as SOPs, preventive maintenance plans, and training matrices.
• Collaborate cross-functionally to analyze repetitive issues and implement corrective solutions.
• Apply quality systems to uphold regulatory compliance.
• Comply fully with Sanofi’s safety policies, Health & Safety regulations, and OSHA standards.
• Support multi-disciplinary engineering initiatives aimed at improving reliability and operational efficiency.

Qualifications & Desired Skills

• Bachelor’s degree in Engineering or a related technical field from an accredited university.
• At least 3 years’ experience in maintenance management and reliability engineering within plant operations or engineering settings.
• Experience in pharmaceutical manufacturing or petrochemical processes preferred.
• Proficient with reliability engineering methodologies such as FMEA, RCM, MTBF, life-cycle cost analysis, Pareto principles, and root cause failure analysis.
• Knowledge of predictive maintenance technologies and the interpretation of condition-monitoring data.
• Familiarity with SAP CMMS or similar computerized maintenance management systems is an advantage.
• Strong project management capabilities including scheduling and reporting.
• Excellent verbal and written communication skills for interactions with various stakeholders.
• A collaborative and team-oriented approach focused on achieving shared objectives.