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 role in Leiden, Netherlands. The position involves creating and managing compliant technical documentation in a regulated environment while ensuring regulatory compliance and collaborating across various teams. **

Job Summary

  • The role is responsible for creating and maintaining compliant technical documentation across regulated products and systems to ensure accuracy and consistency.
  • This position combines expertise in managing equipment status, master data, and inventory through SAP/ERP systems while adhering to strict quality standards.
  • Candidates must collaborate with cross-functional teams including Engineering, Quality Assurance, and Regulatory Affairs to support global documentation initiatives.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Sr Engineer for Technical Documentation and SAP Specialist role in Leiden, Netherlands. The position involves creating and managing compliant technical documentation in a regulated environment while ensuring regulatory compliance and collaborating across various teams. **

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 in regulated pharma
  • Quality system requirements GxP knowledge

Nice-to-have

  • Experience with Johnson & Johnson Credo values
  • Supporting global alignment of documentation
  • Background in engineering or quality affairs
  • Knowledge of EU MDR technical structures
  • Experience supporting audits and inspections

Key Requirements

  • Bachelor's degree in technical or scientific field
  • 3-5 years experience in regulated environment
  • Proficiency with document management systems like TeDis or Meridian
  • Familiarity with FDA 21 CFR Parts 820 and 11
  • EU MDR and ISO 13485 standard knowledge

Work Rights

Not specified

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