Senior Process Engineer, Pto

Merck & Co., Inc.

Rahway, NJ, USA
3 to 5 years technical experience
Cgmp guidelines compliance
New product development expertise
The role involves supporting or leading new product introductions by conducting process comparisons and developing cleaning processes

Job Summary

  • The role involves supporting or leading new product introductions by conducting process comparisons and developing cleaning processes.
  • Candidates must demonstrate strength in technical writing for PPQ reports and CMC sections while ensuring regulatory compliance.
  • The position requires active participation in Continued Process Verification and Annual Product Review activities as part of lifecycle management.

Matching Summary

The role involves supporting or leading new product introductions by conducting process comparisons and developing cleaning processes.

Skills & Requirements

Must-have

  • 3 to 5 years technical experience
  • cGMP Guidelines compliance
  • New Product Development expertise
  • Process Engineering skills
  • Sterile Manufacturing knowledge
  • Quality Risk Assessment
  • SOP Writing capabilities

Nice-to-have

  • Continuous Process Improvement
  • Teamwork and collaboration
  • Personal Initiative
  • Adaptability to change
  • Statistical analysis tools
  • Global network sharing

Key Requirements

  • Bachelor's, Master's or Ph.D. degree in technical field
  • 3 to 5 years pharmaceutical manufacturing experience
  • Knowledge of Chemical or Mechanical Engineering
  • Understanding of Quality by Design principles

Work Rights

Not specified

Tailored Resume

Cover Letter