Lead Engineer ODE Automation

2 weeks ago

Central Region, Singapore Randstad – Lonza Full time $120,000 - $180,000 per year

The Lead Engineer of ODE – Automation is responsible for the introduction of automation control systems used to support GMP manufacturing of biologics products, providing subsequent system administration and maintenance oversight of these control systems and associated networks upon transitioning to operation phase.

What you'll get:

  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • Daily company bus from the MRT location near your home to and from the Tuas site.
  • Fully paid medical insurance, with the option to enroll family members at partially subsidized premiums.

The full list of our global benefits can be also found on

What you'll do

  • Perform system administration and routine maintenance activities, including user access management, system monitoring, software configuration, and backup and recovery for control systems and networks.
  • Troubleshoot and support the resolution of control system-related issues and failures, interacting with system vendors as necessary. Identify performance and security gaps to ensure computerized system integrity and proactively seek out improvements and solutions.
  • Coordinate control system policies and procedures to ensure alignment with current regulatory expectations. Conduct control system user training for Lonza staff. Provide office and after-office hours support (based on on-call rotation) to ensure the smooth operation of control systems supporting GMP production. Assist Engineering Support Team, Manufacturing, and MSAT where cross-functional support is required for troubleshooting/root cause analysis.
  • Investigate TrackWise deviations, write-ups for control system failures/errors; review trends and analyze root causes.
  • Assist management in assessing TrackWise change requests, computerized system change controls, and participate in the control system change management process.
  • Support technology transfer by planning and implementing control system changes within project timelines.
  • Maintain familiarity with 21 CFR Part 11 and EU Annex 11 requirements, data integrity requirements, and expectations, as well as common industry practices with respect to GMP computerized system administration and management.
  • Support the team in maintaining inspection readiness at all times. Perform periodic reviews with respect to user authorizations and system audit trails.
  • Assist Data Owners in data audit trail reviews and electronic data retrieval. Any other duties as assigned by Supervisor / Manager.

What We're Looking for

  • Extensive experience with control systems such as Emerson DeltaV, Rockwell FactoryTalk, PlantPax, Allen Bradley, and Siemens.
  • Extensive experience working with different Windows operating systems, server-user architecture, and control system-related infrastructure basics.
  • A solid understanding and knowledge in automation design and code development standard methodologies.
  • Outstanding problem-solving skills and the ability to determine effective solutions to complex technical issues.
  • A dedication to quality and the ability to strictly adhere to regulatory requirements.
  • Excellent communication and collaboration skills to work effectively within a world-class team.
  • A proactive attitude towards identifying and implementing improvements.

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