Description
**Seniority Level**
Mitarbeiter
**Berufskategorie**
IT
**Stellenprozent**
100 %
**Jobtyp**
Temporär
**Referenz-Nr.**
AFE-IT-T-47835
### **Beschreibung** ###
As a first-tier supplier to our renowned business client, F. Hoffmann-La Roche Ltd. based in Kaiseraugst we are looking for a motivated **Manufacturing System Engineer (m/f/d)** for a 12 month assignment with the option to extend.
We Make Medicines!%u200B
%u200BBehind every product sold by Roche%u200B is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes 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.
### 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
### Benefits: ###
* Enjoy exclusive discounts all year round at renowned retailers and over 200 top brands
* Benefit from fleet discounts when purchasing a new car or receive consistent fuel discounts with our fuel card
* Be part of one of the most prestigious pharmaceutical companies and actively shape the future of healthcare
* Work on a state-of-the-art campus with green spaces, social areas, and an inspiring atmosphere
* Take advantage of attractive fitness and swimming pool offers or use the gaming room as a creative retreat
Have we sparked your interest?
Don't hesitate and submit your complete application documents online today.
We look forward to hearing from you!