Expertise in ppq protocols and validation processes
Merck & Co., Inc. is seeking a Lead Process Engineer in Rahway, New Jersey, to oversee new product introductions and the transfer of drug products, ensuring compliance and process optimization. The ideal candidate will have a strong background in pharmaceutical manufacturing, with at least 5 years of relevant experience and 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 manage process safety management activities, risk assessments, and continuous improvement initiatives across the site.
Candidates must possess a Bachelor's, Master's, or Ph.D. degree in a technical field and have at least 5 years of experience in the pharmaceutical manufacturing industry.
Matching Summary
Match Score: 85
Merck & Co., Inc. is seeking a Lead Process Engineer in Rahway, New Jersey, to oversee new product introductions and the transfer of drug products, ensuring compliance and process optimization. The ideal candidate will have a strong background in pharmaceutical manufacturing, with at least 5 years of relevant experience and advanced technical knowledge.
Skills & Requirements
Must-have
5 years pharmaceutical manufacturing experience
Advanced knowledge of process design and scale-up
Expertise in PPQ protocols and validation processes
Strong technical writing for regulatory documentation
Ability to lead complex technical investigations
Nice-to-have
Experience with sterile boundaries and Cpk analysis
Knowledge of global technology transfer best practices
Leadership behaviors aligned with inclusion standards
Familiarity with MPS production system tools
Proactive Process Analysis (PPA) statistical skills
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