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Engineer 2, Control Systems
2 weeks ago
Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five 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 Engineer, Control Systems is responsible for the introduction of computerized systems, such as Manufacturing execution systems, site historian, analytical systems used to support GMP manufacturing of biologics products. The incumbent shall continue to provide system administration and maintenance oversight of the computerized systems upon their transition to operation phase, ensuring the availability of these GMP systems to the end-user.
**Key responsibilities**:
- Perform system and routine maintenance activities, including but not limited to user access management, system monitoring, software configuration, backup and recovery for control systems and networks.
- Provide support to resolve control system-related issues and failures by fixing and solving them, and engage with system vendors as required.
- 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 requirements.
- 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 department where multi-functional support is needed to address and find root causes.
- 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.
- Own change controls to plan and implement changes within stipulated timelines, meeting GDP and GMP requirements.
- Support control systems Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT) and other site qualification activities as needed.
- You should be familiar with 21 CFR Part 11 and EU Annex 11 requirements. Also, you need to know about data integrity requirements and expectations. Additionally, you should be aware of common industry practices related to GMP computerized system administration and management.
- Support the team to ensure 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 or Diploma in Computer Science, Engineering, Information Systems or a related field.
- Relevant work experience in the design, implementation and/or support of instrumentation and control systems, preferably in the Bio-Pharmaceutical, Pharmaceutical, F&B industry.
- Experience with distributed control system, software development methodologies and automated system life cycle support in a regulated industry.
- Experience with various Windows operating systems, server architecture and control system-related infrastructure fundamentals.
- Proficiency in implementing standard methodologies for automation design and code development.
- Good understanding of cGMP’s requirements particularly as they relate to the operation, validation and maintenance of computer-controlled systems.
- Strong problem-solving and analytical skills.
- A valuable teammate, capable of working collaboratively with different 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 dif
