Senior OT Engineer

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.

• GMP Computerized Systems Administration of GxP lab system software_,_ including installation, backup, archival of data and general data management
• GMP Computerized Systems Validation – support with the implementation- and validation of brand new computerized systems. Including writing and review of validation protocols and reports.
• Second level ‘back-end’ support 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 actions
• Maintain and understanding of new technology and their application to the department.
• Collaboration with the end users within the department to enable their efficient use of the laboratory system
• 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.
• Supporting the change management process for new software or software updates: creating design specification, feedback on software setup on the Lonza OT environment etc.
• Familiarity with Cell and Gene Therapies cGMPs, GAMP and basic validation practices (IQ/OQ/PQ)