Npi/tech Transfer Specialist

Merck Sharp & Dohme LLC

Rahway, New Jersey, USA
Hybrid
Process development studies
Equipment qualification and validation
Cgmp compliance
Supporting New Product Introductions/Technical Transfers is a primary responsibility, involving process, technical, and validation support for manufacturing operations

Job Summary

  • Supporting New Product Introductions/Technical Transfers is a primary responsibility, involving process, technical, and validation support for manufacturing operations.
  • Accountable for analytical/engineering studies, equipment qualification/validation, and authoring/executing process development studies in line with cGMP.
  • Drive compliance with Global Policies, Procedures, and Guidelines, and participate in audits and inspections while fostering a safe and compliant culture.

Matching Summary

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

Skills & Requirements

Must-have

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

Nice-to-have

  • Cross functional team leadership
  • Global technical forums
  • Patient-centric solutions
  • Diverse and inclusive environment

Key Requirements

  • Bachelor's Degree or higher
  • Manufacturing experience in GMP setting
  • Knowledge of regulatory requirements
  • Sterile filling processes and equipment

Work Rights

Not specified

Tailored Resume

Cover Letter