Npi/tech Transfer Specialist

medhunter.de

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

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.
  • Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities, and co-ordination, design and execution of equipment qualification and validation.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities.

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.

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

  • Lean Six Sigma Methodology experience
  • Cross functional team leadership
  • Drive a safe and compliant culture

Key Requirements

  • Bachelor’s Degree or higher preferred
  • Relevant experience in manufacturing, preferably GMP
  • Knowledge of regulatory/code requirements
  • Sterile filling processes and equipment knowledge
  • Lean Six Sigma Methodology experience desired

Work Rights

Not specified

Tailored Resume

Cover Letter