Manufacturing Systems Engineer (MES / IT / OT / GMP) – Basel (m/f/d)

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)