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.
Key responsibilities:
Provide expertise and ownership to the range of computerized systems used in the laboratory.
GMP Computer Systems Administration (e.g. Empower, Softmax Pro, Electronic Lab Notebook) including system back-up, audit trail review, user access administration.
GMP Computer Systems Validation – support the implementation and validation of new systems to be used for cGMP analytical activities including the writing and review of validation protocols and reports. This responsibility includes periodic revalidation of the equipment.
Strategic deployment of software upgrades including training of end users as required.
Develop expertise to be able to represent the department during audits by customers and regulatory bodies.
Understanding and management for all other laboratory systems controlling operational technology in the department for example in the area of upstream process development.
Support the end users in day-to-day operation of software/systems and able to identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/ or corrective action records as well as via liaison with vendors.
Maintain an understanding of new technology and their application to the department.
Collaboration with end users within the department to enable their efficient use of the laboratory systems.
Collaborate with departments in Singapore and across the global Lonza network (e.g. QC/IT/QA/Development).
Key requirements:
Degree/Diploma in a relevant Science field or Equivalent
Relevant work experience preferably with laboratory related IT experience in a biotechnology or related medical field.
Expertise in computer systems controlling laboratory equipment (e.g. Empower).
Exposure to cGMP and experience in computer system validation.
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.
Exposure to basic programming concepts and databases.
Excellent problem solving and analytical skills and experience working within a formal Quality Management System (cGxP/ISO)
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.
