Our 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 initiative
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)