Overview
Our client, a leading pharmaceutical organization, is looking for a Manufacturing System Engineer to join their team in Basel. This is a fantastic opportunity to work in a GMP-regulated environment, supporting and optimizing MES systems that play a critical role in delivering life-saving medicines.
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 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
Qualifications
* 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.
Skills
* GMP
* MES
* German
* CSV
Employee Value Proposition
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.
Job Title: Manufacturing System Engineer
Location: Basel, Switzerland
Job Type: Contract
Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.
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