Senior Process Engineer, Pto

539

Rahway, NJ, USA
**
3 to 5 years pharmaceutical manufacturing experience
Bachelor's degree in chemical or biological sciences
Knowledge of cgmp guidelines and regulatory requirements
** The Senior Process Engineer position at Merck in Rahway, NJ, involves leading new product introductions and providing technical guidance in pharmaceutical manufacturing processes. The ideal candidate should have a technical background, preferably in engineering or biological sciences, along with experience in the pharmaceutical industry. **

Job Summary

  • The role involves supporting or leading new product introductions including process comparisons, raw material introduction, and clinical supply manufacturing.
  • Candidates must demonstrate strength in technical writing for change requests, PPQ reports, and CMC sections while ensuring compliance with regulatory standards.
  • The position requires proactive identification of solutions for deviations and providing technical expertise for audits, regulatory support, and continuous process verification.

Matching Summary

Match Score: 75

** The Senior Process Engineer position at Merck in Rahway, NJ, involves leading new product introductions and providing technical guidance in pharmaceutical manufacturing processes. The ideal candidate should have a technical background, preferably in engineering or biological sciences, along with experience in the pharmaceutical industry. **

Skills & Requirements

Must-have

  • 3 to 5 years pharmaceutical manufacturing experience
  • Bachelor's degree in Chemical or Biological Sciences
  • Knowledge of cGMP guidelines and regulatory requirements
  • Experience with new product introductions and technical transfer
  • Proficiency in process validation and cleaning validation

Nice-to-have

  • Strong technical writing skills for PPQ reports
  • Understanding of Quality by Design (QbD) principles
  • Experience with statistical analysis tools like Cpk
  • Leadership behaviors in safety walks and PHA activities
  • Collaboration across global S&T network

Key Requirements

  • Bachelors, Masters or Ph.D. in technical field
  • 3 to 5 years technical experience in pharmaceutical industry
  • Valid work authorization not explicitly specified

Work Rights

Not specified

Tailored Resume

Cover Letter