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.
Role Purpose:
You will ensure the calibration between software is up to date, will align changes with the Business Process Owner and ensures their implementation, and works together with the team to ensure incident resolution. You will also work globally for various sites using CMX for calibration.
As the SAP Implementation Lead, you will be part of the SAP PM and Beamex team. You will need SAP PM working knowledge.
Key Accountabilities and Duties:
Responsible for the implementation of the approved authorization concept.
Availability Management: Point of contact for relevant parties associated with major disruptions and/or amendments to the allocated product lines.
Act as escalation point and coordinator (as required) for resolution of major outages.
Liaison with the Process Owner and external suppliers to ensure that support services (and licensing) are suitable and maintained.
Work together with an external vendor to ensure delivery on defined KPIs for systems/services.
Ensure delivery of capacity and capability Beamex / CMX to the end user.
Work with Process Owner to ensure technical capacity scales appropriately for the delivery of product enhancements and other changes.
Monitor system performance and ensure that appropriate maintenance measures are implemented.
Configuration management as defined in the system documentation.
Ensure that procedures required for the maintenance of the system exist and are followed.
Establish and implement a disaster recovery plan and ensure that it is regularly reviewed and tested.
Answer technical questions during regulatory inspections and customer/internal audits.
Ensure that changes are managed in accordance with applicable procedures.
Ensure that CMX's availability, support, maintenance, validation, and security are in compliance with GxP requirements.
Coordinates technical activities with Process and Data owners.
Skills / Qualifications:
Experience implementing IT solutions and performing tasks in a regulated pharmaceutical production environment.
Experience with Beamex.
Experience with SAP PM – CMX Interface.
Alternatively: Experience with other calibration software.
Experience with business processes around calibration.
Experience in managing GxP applications for life science, including Computer System Validation activities.
Experience with System Life Cycle Documentation.
Preferred: Education in Computer Science or other IT field of study.
Excellent written and verbal communication skills.
Ability to work on multiple tasks/projects simultaneously.
Ability to work proactively and independently.
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.
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