Npi/tech Transfer Specialist

Mayoly

Hybrid
Process development studies
Equipment commissioning and qualification
Cgmp compliance
Supporting New Product Introductions/Technical Transfers is a primary responsibility, involving process, technical, and validation support for operations and new product introduction

Job Summary

  • Supporting New Product Introductions/Technical Transfers is a primary responsibility, involving process, technical, and validation support for operations and new product introduction.
  • Accountable for analytical/engineering studies, equipment qualification/validation, and providing technical input into quality notifications and investigations.
  • Drive compliance with Global Policies, Procedures, Guidelines, and cGMP, while collaborating to foster a safe and compliant culture.

Matching Summary

Supporting New Product Introductions/Technical Transfers is a primary responsibility, involving process, technical, and validation support for operations and new product introduction.

Skills & Requirements

Must-have

  • Process development studies
  • Equipment commissioning and qualification
  • cGMP compliance
  • Lean Six Sigma methodologies
  • Root cause analysis
  • Technical writing

Nice-to-have

  • Excellent communication skills
  • Team-oriented manner
  • Flexible approach
  • Effective time management
  • Strong influencing skills
  • Risk management skills

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter