Oorspronkelijke vacature omschrijving:
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.
The OT Engineer will be taking care of the (process & equipment related) IT challenges within our Lonza site.
Key responsibilities:
- Ensure that adequate standards are maintained, communicated and effectively implemented for all systems and associated computer infrastructure
- Consult and advise computer systems projects on the correct application of internal and external regulations
- Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans.
- Ensure that the internal regulations are in line with up to date regulatory requirements.
- Ensure that the lab application software package can work in the Lonza OT environment, provide support to configure proper setup
- Support in validation documentation, creation of design specifications
- Ensure that the change management process for evaluating new or revised software is implemented and that the appropriate validation activities are identified and carried out
- Familiarity with Cell and Gene Therapies cGMPs, GAMP and basic validation practices (IQ/OQ/PQ)
Key requirements:
- Bachelor or Masters
- At least 5 years of relevant working experience
- Problem solving mindset
- Dutch working permit
- Experience with GMP
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.
