Lead Process Engineer, Pto

Merck & Co., Inc.

Rahway, New Jersey, USA
Not specified
5 years pharmaceutical manufacturing experience
Chemical engineering or pharmaceutical sciences degree
Advanced knowledge of process design and scale-up
The Lead Process Engineer at Merck & Co., Inc. in Rahway, NJ, will be responsible for overseeing new product introductions and the transfer of drug products, providing technical guidance, and leading process improvement initiatives. The ideal candidate should have extensive experience in pharmaceutical manufacturing and possess advanced technical knowledge

Job Summary

  • The PTO Lead Process Engineer leads new product introductions and the transfer of drug products to other facilities independently while serving as a coach for colleagues.
  • This role requires advanced technical knowledge to anticipate and remediate quality issues arising from technology transfer processes and ensure robust process designs.
  • Candidates will act as primary regulatory representatives for moderately complex products and lead compliance activities including audits and regulatory support.

Matching Summary

Match Score: 85

The Lead Process Engineer at Merck & Co., Inc. in Rahway, NJ, will be responsible for overseeing new product introductions and the transfer of drug products, providing technical guidance, and leading process improvement initiatives. The ideal candidate should have extensive experience in pharmaceutical manufacturing and possess advanced technical knowledge.

Skills & Requirements

Must-have

  • 5 years pharmaceutical manufacturing experience
  • Chemical Engineering or Pharmaceutical Sciences degree
  • Advanced knowledge of process design and scale-up
  • Experience with PPQ protocols and validation
  • Root cause analysis and deviation management skills
  • Technical writing for regulatory documentation
  • Leadership in capital projects and facility start-ups

Nice-to-have

  • Statistical analysis and risk assessment tools
  • Global collaboration and best practice sharing
  • EHS leadership and Process Hazard Analysis
  • Continuous process improvement methodologies
  • Project management and stakeholder influence

Key Requirements

  • Bachelor's, Master's, or Ph.D. in Chemical Engineering, Mechanical Engineering, Chemistry, or Pharmaceutical Sciences
  • Minimum 5 years of technical experience in pharmaceutical manufacturing industry
  • Work authorization status not specified in posting

Work Rights

Not specified

Tailored Resume

Cover Letter