Lead Engineer, ODE – Automation

Singapore, Tuas Singapore

Lonza is the pioneer and world leader in the CDMO industry operating across 5 continents, setting the pace with cutting-edge science, smart technology and lean manufacturing. We turn our customers' break-through innovations into viable therapies and manufacture the medicines of tomorrow.At the heart of every scientific breakthrough are talented individuals collaborating to develop solutions that empower businesses to improve lives. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. As a Biotechnologist at Lonza Mammalian business, you'll be part of our globally recognized network, driving the production of mammalian cell culture and treatments.

Join our best-in-class high performance Integrated Biologics team at our Tuas site in Singapore to gain unparalleled exposure to cutting-edge biotechnology and innovation, and make a difference from day one. Learn new skills and capabilities, and grow your career with us in manufacturing therapeutic proteins under cGMP conditions. Find out more about what a life at Lonza in Singapore could look like for you by watching this short video.

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.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R68629

Apply

Similar Jobs

R71310