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Lead Engineer
2 weeks ago
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 (Systems)** is responsible for the implementation of GMP computerized systems and providing subsequent system administration and maintenance support of the computerized systems upon transitioning to operation phase.
**Key responsibilities**:
- Support site projects involving the introduction and/or upgrades of computerized systems to support GMP operations.
- Perform system administration activities (user access administration, system software configuration, system maintenance, backup and recovery) for GMP computerized systems.
- 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.
- Maintain system integrity and identify performance and security improvements.
- Provide office as well as after-office hours support (based on on-call rotation) to Manufacturing.
- Participate in computerized system change management process.
- Perform troubleshooting and provide support to resolve computerized system related issues and failures; interactions with Lonza IT, system / equipment manufacturers and/or vendors as necessary.
- Own and perform deviation investigation and writeup on computerized system failures / errors; deviation trend review and root cause analysis as required per Lonza Quality requirements.
- Oversight of computerized system policies and procedures to ensure alignment with current regulatory expectations.
- 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.
- Any other duties as assigned by Supervisor / Manager.
**Key requirements**:
- Degree/Diploma in Computer Science, Engineering, Information Systems or Equivalent.
- Experience with servers, storage, network, switches and related infrastructure fundamentals.
- Experience with various operating systems such as Windows, Linux.
- Working knowledge of programming languages such as VB script,.NET, SQL is preferred.
- 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: R52340**:
