QC Support Expert

Sanofi EU; Singapore; On-site; SGD 100,000 - 130,000; Full time

Job summary

A global biopharmaceutical company in Singapore is seeking an experienced data management specialist to administer and troubleshoot their Kepware and Aspen IP.21 systems. The ideal candidate will have over 8 years of experience in a GxP-regulated environment, with proficiency in SQLplus and data integrity management. This role offers the opportunity to contribute to innovative manufacturing processes and ensure compliance with industry standards.

Qualifications

• Minimum 8 years of experience in administering Kepware platform.
• Practical background in GxP-regulated environments.
• Experience with DeltaV DCS or Siemens PLC/WinCC.

Responsibilities

• Administer and troubleshoot the Kepware connectivity platform.
• Design data extraction processes for Manufacturing Execution Systems.
• Ensure compliance with GMP requirements and industry standards.

Skills

Kepware platform administration

Aspen IP.21 database troubleshooting

SQLplus query optimization

GxP compliance understanding

Data integrity management

Tools

Aspen SQLplus

DeltaV DCS

Siemens PLC/WinCC

Job description

Sanofi Manufacturing and Supply organization is preparing its future through an ambitious program named Modulus. The Modulus 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 well as Specialty Care Biologics products.

Main Accountabilities

• Administer, maintain, and troubleshoot the Kepware connectivity platform and the Aspen IP.21 real-time database.
• Configure new devices, tags, and data flows within Kepware to integrate data from PLCs, DCS and analytical equipment.
• Design, develop, and maintain robust data extraction and transformation logic using Aspen SQLplus to create reliable data feeds for Manufacturing Execution Systems (MES) and other business applications.
• Ensure reliable and secure data flow from OT-level systems (via Kepware) to the IP.21 historian and other IT-level systems.
• Implement system change controls, upgrades, perform backups, and ensure system security and compliance with GMP requirements and industry standards.
• Create and maintain documentation for system configurations, interfaces, and standard operating procedures.
• Collaborate with cross-functional teams to support process optimization, troubleshooting, and regulatory compliance initiatives.
• Decide on specific configuration parameters for tags, devices, and channels within Kepware and data points within IP.21, adhering to established architecture.
• Determine the technical approach, writing, and optimization of SQLplus queries and scripts for data extraction and transformation.
• Make immediate decisions during incident response and execute standard operational procedures for system health and recovery.
• Advise on system architecture, technology upgrades, capacity planning, and the introduction of new drivers or integration tools.
• Provide technical analysis and recommendations for new projects and major changes, including risk assessments and implementation plans.
• Develop and propose SOPs, backup strategies, and contribute to GxP validation documentation.
• Be informed of team goals, priority shifts, and relevant decisions from other IT/OT projects that may impact the data systems.
• Receive regular performance feedback and be notified of major team-wide incidents or approved changes.

Expected Experience

• Minimum 8 years' experience in administering, configuring, and troubleshooting the Kepware (KEPServerEX) platform and AspenTech IP.21 real-time database.
• Practical background in supporting OT/IT data infrastructure within a GxP-regulated environment, with a clear understanding of data integrity and GMP standards.
• Experience in DeltaV DCS or Siemens PLC/WinCC.