Npi/tech Transfer Specialist

Merck Sharp & Dohme LLC

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

Job Summary

  • Supporting New Product Introductions/Technical Transfers is a primary responsibility, involving process, technical, and validation support for operations and manufacturing processes.
  • Accountable for analytical/engineering studies, equipment qualification/validation, and process development in support of new product introduction and ongoing manufacturing.
  • Drive compliance with Global Policies, Procedures, Guidelines, regulatory requirements, and cGMP, 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 operations and 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 Methodologies
  • Cross functional team leadership
  • Safe and compliant culture

Key Requirements

  • Bachelor’s Degree or higher
  • Experience in a GMP setting
  • Knowledge of regulatory/code requirements
  • Sterile filling processes and equipment
  • Lean Six Sigma Methodology experience

Work Rights

Not specified

Tailored Resume

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