Npi/tech Transfer Specialist

Mericalherbs

Hybrid
Process, technical, and validation support
Analytical/engineering studies
Equipment qualification and validation
Supporting New Product Introductions/Technical Transfers, this role is responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction

Job Summary

  • Supporting New Product Introductions/Technical Transfers, this role is responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.
  • Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities, and coordination, design and execution of equipment qualification and validation as required.
  • Serve as technical engineering representative for internal technical group discussions and represent site at global technical forums, participating and/or leading cross functional or single function teams.

Matching Summary

Supporting New Product Introductions/Technical Transfers, this role is responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction.

Skills & Requirements

Must-have

  • Process, technical, and validation support
  • Analytical/engineering studies
  • Equipment qualification and validation
  • Process development studies
  • Root cause analysis of system failures
  • cGMP compliance

Nice-to-have

  • Continuous improvement through Lean Six Sigma
  • Cross functional team participation
  • Drive a safe and compliant culture

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
  • Lean Six Sigma Methodology experience desired

Work Rights

Not specified

Tailored Resume

Cover Letter