Sr Serialization Engineer

Fresenius Kabi

Base: $105,000 - $125,000; bonus: target 6% of bas...
Not specified
Serialization system architecture design
Level 2/3 serialization troubleshooting
Computer system validation (csv) execution
Fresenius Kabi is seeking a Senior Serialization Engineer responsible for the design, implementation, and validation of serialization and packaging systems. The role demands expertise in serialization technologies and project management, ensuring compliance with industry regulations while managing multiple projects simultaneously

Job Summary

  • The Senior Serialization Engineer leads the conceptual design, implementation, and validation of serialization and packaging systems across multiple capital projects.
  • This role requires acting as the primary subject matter expert for Level 2/3 serialization systems to troubleshoot issues and ensure ongoing maintenance in alignment with xGMP requirements.
  • Candidates will manage full project lifecycle activities including planning, scheduling, resource allocation, and closure while ensuring adherence to scope, timeline, and budget constraints.

Matching Summary

Match Score: 85

Fresenius Kabi is seeking a Senior Serialization Engineer responsible for the design, implementation, and validation of serialization and packaging systems. The role demands expertise in serialization technologies and project management, ensuring compliance with industry regulations while managing multiple projects simultaneously.

Salary

Base: $105,000 - $125,000; Bonus: Target 6% of base salary; Benefits: 401(k) with company contributions, medical, dental, vision, paid vacation

Skills & Requirements

Must-have

  • Serialization system architecture design
  • Level 2/3 serialization troubleshooting
  • Computer System Validation (CSV) execution
  • xGMP and FDA cGMP regulatory compliance
  • Packaging line equipment integration
  • DSCSA and EPCIS data standards knowledge

Nice-to-have

  • Experience with Systech or Optel platforms
  • Vision system technology expertise
  • Cross-functional team leadership skills
  • Feasibility study and benchmarking abilities
  • Strong IT/OT interface understanding

Key Requirements

  • Bachelor's degree in Electrical or Computer Engineering
  • Minimum 5 years of relevant industry experience
  • Hands-on experience with serialization platforms like Systech or Optel

Work Rights

Not specified

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