Overview
4 days ago Be among the first 25 applicants
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.
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.
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
Have we sparked your interest? We look forward to receiving your complete application documents.
Senioriy level
* Mid-Senior level
Employment type
* Full-time
Job function
* Information Technology and Consulting
Industries
* IT Services and IT Consulting
* Biotechnology Research, and Pharmaceutical Manufacturing
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