Npi/tech Transfer Specialist

39med

Hybrid
Process, technical, and validation support
Equipment qualification and validation
Process development studies
This role supports New Product Introductions and Technical Transfers, providing process, technical, and validation support for manufacturing operations

Job Summary

  • This role supports New Product Introductions and Technical Transfers, providing process, technical, and validation support for manufacturing operations.
  • Key responsibilities include designing, authoring, reviewing, and executing validation documentation and studies, as well as performing data analysis and root cause analysis for system failures.
  • The company is committed to patient well-being and embraces diversity and inclusion to drive innovation in addressing challenging healthcare needs.

Matching Summary

This role supports New Product Introductions and Technical Transfers, providing process, technical, and validation support for manufacturing operations.

Skills & Requirements

Must-have

  • Process, technical, and validation support
  • Equipment qualification and validation
  • Process development studies
  • Root cause analysis of system failures
  • cGMP compliance
  • Risk assessments

Nice-to-have

  • Lean Six Sigma Methodology experience
  • Cross functional team participation
  • Continuous improvement initiatives

Key Requirements

  • Bachelor’s Degree or higher preferred
  • Relevant experience in manufacturing, preferably GMP setting
  • Knowledge of regulatory/code requirements
  • Equipment and process validation experience
  • Sterile filling processes and equipment knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter