Lead Engineer

Singapore, Tuas SingaporeToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. 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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience - we, in Singapore are proud to be part of this global network.

The **Lead Engineer** 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.

**Key responsibilities**:

- Perform system administration and routine maintenance activities, including but not limited to user access management, system monitoring, software configuration, backup and recovery for control systems and networks.
- Perform troubleshooting and provide support to resolve control system-related issues and failures; interactions with system vendors as necessary.
- Identify performance and security gaps to ensure computerized system integrity and proactively seeks out improvements and solutions.
- Oversight of control system policies and procedures to ensure alignment with current regulatory expectations.
- Conduct control system user training to Lonza staff.
- Provide office as well as after-office hours support (based on on-call rotation) to ensure smooth operation of the control systems supporting GMP production.
- Provide assistance to Engineering Support Team, Manufacturing, MSAT where cross-functional support is required for troubleshooting/root cause finding.
- Own and perform TrackWise deviation investigations and write-up on control system failures/errors; deviation trend review and root cause analysis as required per Lonza Quality requirements.
- Assist management in assessing TrackWise change requests, computerized system change controls and participate in control system change management process.
- As Control Systems SME to support technology transfer and other site capital projects by performing scoping of control system-related changes; plan and execute changes within project timelines.
- Lead control systems Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT) and support subsequent site qualification activities as needed.
- 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 on inspection readiness at all times.
- Perform periodic reviews with respect to user authorizations and system audit trails.
- Support Data Owners in data audit trail reviews in terms of electronic data retrieval.
- Any other duties as assigned by Supervisor / Manager.

**Key requirements**:

- Degree/Diploma in Engineering, Computer Science, Information Systems or Equivalent.
- Experience with control systems such as Emerson DeltaV, Rockwell FactoryTalk, PlantPax, Allen Bradley and Siemens.
- Experience with various Windows operating systems, server-client architecture and control system-related infrastructure fundamentals.
- Good understanding and knowledge in automation design and code development best practices.
- Strong problem solving and analytical skills.
- Good communication skills.
- A team player, with the ability to work across functional teams.

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: R58575
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