For our client, a leading pharmaceutical company based in Basel, we are looking for a motivated individual with a strong understanding of business processes related to manufacturing systems, as well as practical knowledge of continuous improvement principles.

Manufacturing System Engineer (a)

Behind every product sold by our client 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.

Your tasks

• 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

Your qualifications

• 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 principle
• Fluency in German and good English, both spoken and written, is essential

Your application

Please apply online. For further information about the position, please contact your Gi Consultant, Mr. Nazim Sagkol (B. Eng.), (+41 76 349 85 07)

Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world. In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton and Bautech Personal. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 40 locations across Switzerland and over 200 employees, we are one of the leading staffing companies in the Swiss recruitment market. Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.