Manufacturing System Engineer
Posted 7 hours 25 minutes ago by Swisslinx
Job Title: Manufacturing System Engineer - IT / OT
Location: Basel, Switzerland
Start Date: As soon as possible (latest 1 December 2025)
Duration: 12 months (extension possible)
Workload: 100%
Onsite/Remote: Primarily onsite with limited home office flexibility
About the Role
Are you passionate about Information Technology (IT) and Automation Technology (OT)? Do you thrive in a customer-focused environment and want to make a meaningful impact in pharmaceutical manufacturing?
As a Manufacturing System Engineer, you will play a key role in supporting, coordinating, and ensuring compliance in laboratory and manufacturing areas. You will also be involved in implementing new systems and enhancements that enable digitalization and continuous improvement in a GMP-regulated environment.
Key Responsibilities
- Manage the Life Cycle of the MES (Manufacturing Execution System)
- Execute master data adjustments in automation systems in line with SOPs
- Support change management, qualification, and validation activities in compliance with internal guidelines
- Perform root cause analysis, validate resolution proposals, and ensure monitoring of business errors in alignment with ITSM principles
- Create and update SOPs and system documentation
- Train new employees on MES processes
- Ensure adherence to GMP, GDP, and data integrity requirements
- Collaborate with other MES teams, business representatives, and stakeholders
- Drive continuous improvement initiatives to streamline processes
Requirements
- Completed apprenticeship in IT, engineering, or equivalent qualification (mandatory)
- Strong knowledge of manufacturing systems administration and support in a GxP-regulated environment
- Solid experience with IT Service Management (ITSM) tools (e.g. ServiceNow) and business deviation tools (e.g. Veeva)
- Proven knowledge of CSV, Annex 11/21 CFR Part 11, GAMP 5, and data integrity guidelines
- Working knowledge of continuous improvement principles
- Fluent German and strong English (spoken and written)
Why Join
- Be part of a team of 12 specialists in IT/OT pharma manufacturing
- Work in a dynamic, GMP-regulated environment with cutting-edge systems
- Contribute to the digital transformation of pharmaceutical manufacturing
- Opportunity for longer-term engagement through contract extension
Application Notes:
- Please upload your degree certificate and latest reference letter.
- Only candidates with completed education can be considered.
- CVs must be submitted in German.
- Interviews will take place remotely at the end of September 2025.