Are you passionate about
Information (IT) and Automation Technology (OT)
and aspiring to make a meaningful impact? You are a customer focused individual with aspiration to deliver high quality support in a GMP environment.
Starting with Phase I of the development process and continuing through to product maturity, the global operations make lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently undergoing a transformation towards digitalization, advancing fundamental elements to meet future needs, such as leveraging new technologies.
As a
Manufacturing System Engineer
, you will be responsible for supporting, coordinating, and ensuring compliance in the laboratory and manufacturing areas, including the implementation of new systems and enhancements.
The perfect candidate
:
We are looking for someone with extensive understanding of business processes related to manufacturing systems and with working knowledge of continuous improvement principles. Additionally we need someone with fluent German skills and strong knowledge with GxP.
General Information
:
• Start date: asap, latest Start Date:
• Planned duration: 12 months, extension (in case of limitation): possible
• Workplace: Basel, Workload: 100%
• Home Office: mostly onsite
Tasks & Responsibilities:
* Responsible for Life Cycle Management of the MES System
* Master data adjustments in the automation systems in accordance with the standard operating procedures applicable within the MES system in Basel
* Implementation, collaboration, and support in change management, qualification, and/or validation activities in accordance with Roche's internal guidelines
* Perform root cause analysis, validate resolution proposals, and ensure compliance and monitoring of business errors in alignment with ITSM principles.
* Creation and revision of documents in the area of responsibility (SOPs), such as the creation of automation and MES-related regulations and SOPs
* Training of new employees to introduce them to MES
* Ensure adherence to regulatory requirements such as Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and other relevant regulations
* Promoting collaboration with other MES teams such as First level Support, Business representatives and other stakeholders
* Continuous improvement process activities to streamline and consolidate processes
Must Haves
* Completed apprenticeship in IT or a related field, or an equivalent qualification
* In-depth understanding of business processes related to manufacturing systems.
* Strong background in systems administration and support for manufacturing systems including strong knowledge with GxP.
* Experience with IT Service Management (ITSM) processes and proficiency in using support tools (e.g. SNOW) for request and change management and business deviation management tools (e.g. Veeva).
* Proven CSV Knowledge / Familiar with Annex 11/21CFR Part 11 requirements, GAMP 5 and data integrity guidelines
* Working knowledge of continuous improvement principles
* Fluency in German and good English, both spoken and written, is essential