Senior Process Engineer, Pto

Merck & Co., Inc.

Rahway, NJ, USA
Not specified
3 to 5 years technical experience in pharmaceutical manufacturing
Bachelor's, master's or ph.d. degree in technical field
Knowledge of cgmp guidelines and quality by design principles
Merck & Co., Inc. is seeking a Senior Process Engineer in Rahway, NJ, to support new product introductions and ensure compliance with manufacturing processes in the pharmaceutical industry. The ideal candidate will have a strong background in process engineering, technical writing, and compliance in a pharmaceutical manufacturing environment

Job Summary

  • The role involves supporting or leading new product introductions including process comparisons, equipment studies, and clinical supply manufacturing.
  • Candidates must demonstrate expertise in developing PPQ protocols, managing validation activities, and ensuring compliance with regulatory requirements.
  • The position requires proactive identification of solutions for production issues while maintaining robust process designs for routine manufacturing.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking a Senior Process Engineer in Rahway, NJ, to support new product introductions and ensure compliance with manufacturing processes in the pharmaceutical industry. The ideal candidate will have a strong background in process engineering, technical writing, and compliance in a pharmaceutical manufacturing environment.

Skills & Requirements

Must-have

  • 3 to 5 years technical experience in pharmaceutical manufacturing
  • Bachelor's, Master's or Ph.D. degree in technical field
  • Knowledge of cGMP Guidelines and Quality by Design principles
  • Experience with PPQ protocols and validation activities
  • Proficiency in sterile manufacturing and mammalian cell culture

Nice-to-have

  • Strong technical writing skills for change requests
  • Ability to lead process hazards analyses (PHA)
  • Collaboration across global company S&T network
  • Experience with Production Systems tools for improvement

Key Requirements

  • Bachelors, Masters or Ph.D. degree in Chemical/Mechanical Engineering, Chemistry, Biological or Pharmaceutical Sciences
  • 3 to 5 years technical experience in pharmaceutical manufacturing industry
  • Valid Driving License (implied by flexible work/travel context if applicable, though not explicitly mandatory)

Work Rights

Not specified

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