Manufacturing Systems Engineer (MES / IT / OT / GMP) - Basel m/f/d, Basel-StadtOur client, a global leader in pharmaceuticals, is seeking a
Manufacturing Systems Engineer to support IT and OT operations in a GMP-regulated environment at their Basel site.
This role is ideal for professionals with experience in
MES (Manufacturing Execution Systems), IT Service Management, CSV compliance, and GxP standards, who are eager to contribute to life-saving medicine production.
Key Responsibilities: - Oversee the life cycle management of MES systems
- Perform master data adjustments in automation systems in line with SOPs
- Support change management, qualification, and validation activities
- Conduct root cause analysis and implement compliant resolutions
- Prepare and revise SOPs and MES-related documentation
- Train new employees on MES usage
- Ensure adherence to GMP, GDP, and data integrity guidelines
- Collaborate with cross-functional teams and contribute to continuous improvement initiatives
Must-Have Qualifications: - Completed apprenticeship in IT or related field, or equivalent qualification
- Strong experience in manufacturing systems administration and GxP compliance
- Proficiency in ITSM tools (e.g., ServiceNow) and business deviation tools (e.g., Veeva)
- Solid CSV knowledge, familiar with Annex 11 / 21 CFR Part 11, GAMP 5
- Working knowledge of continuous improvement principles
- Fluency in German and good command of English (spoken and written)
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