Manufacturing System Engineer (m/f/d)
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
Profile
- 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
- International and diverse environment
- World-renowned pharmaceutical company
- Internal career opportunities
- Work at the forefront of science and technology: contribute to developing innovative diagnostics and life-saving treatments, helping millions of patients worldwide live healthier, longer lives
About Hays
IT is and always has been our core business that laid the foundation for Hays' success. We are the biggest privately owned IT recruitment agency in Germany and offer the best jobs for every career level – whether you are interested in vacancies in agile SMEs or international DAX groups. Hays masters the entire IT job spectrum, from support to software architecture or digitalisation – thanks to our broad portfolio, we have something for everyone. In the last decades, we were able to support numerous IT experts with choosing the right path for a successful career, positioning ourselves as their lifelong partner. Our highly specialised consultants can cater to your every wish and expectation and will prepare you for interviews and contract negotiations. Give it a try and learn what the market has to offer – our services are free of charge, non-binding and discreet! We look forward to hearing from you.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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