Sr Engineer Fm Technical Documentation And Sap Specialist
Johnson & Johnson
Leiden, South Holland, Netherlands
**
3-5 years technical documentation experience
Sap erp equipment and inventory management
Regulatory compliance fda eu mdr iso standards
**
Johnson & Johnson is seeking a Sr Engineer for Technical Documentation and SAP Specialist in Leiden, Netherlands, to manage compliant technical documentation across regulated products and systems. The role requires expertise in regulatory compliance, technical writing, and SAP management within a healthcare environment, emphasizing collaboration and continuous improvement.
**
Job Summary
The role is responsible for creating, managing, and maintaining compliant technical documentation across regulated products and systems within a highly regulated pharma environment.
This position combines expertise in SAP/ERP to manage equipment status, master data, and inventory while ensuring alignment with global regulatory requirements.
Candidates must collaborate with cross-functional teams including Engineering, Quality Assurance, and Manufacturing to support documentation accuracy and traceability.
Matching Summary
Match Score: 75
**
Johnson & Johnson is seeking a Sr Engineer for Technical Documentation and SAP Specialist in Leiden, Netherlands, to manage compliant technical documentation across regulated products and systems. The role requires expertise in regulatory compliance, technical writing, and SAP management within a healthcare environment, emphasizing collaboration and continuous improvement.
**
Skills & Requirements
Must-have
3-5 years technical documentation experience
SAP ERP equipment and inventory management
Regulatory compliance FDA EU MDR ISO standards
Document lifecycle management and version control
Experience with document management systems
Nice-to-have
Johnson & Johnson or similar multinational experience
Supporting audits and regulatory inspections
Engineering or quality background preferred
Knowledge of EU MDR technical structures
Continuous improvement and digitalization initiatives
Key Requirements
Bachelor's degree in technical, scientific, or quality field
3-5 years experience in regulated medical device or pharma industry
Proficiency with TeDis, Meridian, or similar document management systems
Solid understanding of FDA 21 CFR Parts 820, 11 and ISO 13485