Job Description

For our client, a well-known pharmaceutical company in Basel, we are looking for a Manufacturing System Engineer (m/f/d).

Background

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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

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Start date: asap Latest Start Date: 01.12.25 Planned duration: 31.12.26 Extension: possible Workplace: Basel Workload: 100% Travel: no

Tasks and Responsibilities

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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 our 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

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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

Nice to Have:

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Direct experience working with biomedical, scientific, or other technical document formats Familiarity with advanced data splitting techniques for multi-label datasets Experience with MLOps principles and tools

Contact

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Jan Schmitz-Elsen

Talent Acquisition Consultant

+41 61 500 01 74

jan.schmitz@datalynx.ch