Systems Specialist 3, Quality Control

Systems Specialist 3, Quality Control

Today, 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.

As a Specialist, you will be responsible for support and administration (system back-up, user access administration) for LIMS, MODA and other related Laboratory computerized systems. This role also requires processing LIMS and MODA static data requests.

Responsibilities

1. Support and administration (system back-up, user access administration) for Sample Manager LIMS, MODA LIMS, iLAB, and other related Laboratory computerized systems.
2. Maintenance of LIMS static data (Sample Manager LIMS, MODA LIMS and STATISTICA systems).
3. Support for installation and qualification/validation of software related aspects of computerized instrumentation.
4. Actively contributes to operational efficiency/continuous improvement initiatives.
5. Support system audit trail review of all related Laboratory computerized systems.
6. Maintenance of software related changes to computerized instruments.
7. Server and database maintenance and administration as relates to laboratory systems.
8. Provide training for the roll-out of new computerized systems.
9. Generation and execution of computer validation documentation (protocols and reports).
10. Identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/or corrective action records.
11. System/equipment manufacturer and or vendor interaction as required to troubleshoot system issues.
12. Available to troubleshoot and resolve critical system issues as they occur.
13. Experience managing projects (people/team environment) to meet the timelines.
14. Customer and regulatory agency interaction as required.
15. Oversight of computer system policies and procedures to ensure policy is aligned with current regulatory expectations.
16. Familiarity with 21 CFR Part 11 and EU Annex 11 requirements, data integrity requirements and expectations as well as common industry practice with respect to laboratory computerized system management and administration.
17. SME in 1 or more areas as aligned with training plan.

Experience

1. Degree/Diploma in relevant Science field or Equivalent.
2. Minimum 5 years of experience.
3. Relevant work experience preferably Lab related IT experience in a biotech or medically related field.
4. Experience in lab computer systems essential (prefer experience with LIMS, and CDS –Chromatography Data Systems).

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.