Npi/tech Transfer Specialist

539

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 coordination, design and execution of equipment qualification and validation.
  • Drive compliance of company's 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
  • Quality notification investigations
  • Lean Six Sigma methodologies
  • cGMP compliance

Nice-to-have

  • Cross functional team leadership
  • Global technical forums representation
  • Vendor and above site liaison
  • Safe and compliant culture
  • Customer service skills
  • Risk management skills
  • Influencing skills

Key Requirements

  • Bachelor's Degree or higher preferred
  • Relevant experience in manufacturing, preferably GMP setting
  • Knowledge of regulatory/code requirements
  • Report, standards, policy writing skills
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office

Work Rights

Not specified

Tailored Resume

Cover Letter