The Lead Process Engineer at Merck & Co. is responsible for leading new product introductions and overseeing the transfer of drug products while providing technical support and guidance. The role requires advanced knowledge in pharmaceutical manufacturing processes, with a focus on continuous improvement and compliance
Job Summary
The Lead Process Engineer leads new product introductions and the transfer of drug products to other facilities independently while coaching colleagues.
This role requires advanced technical knowledge to manage investigations, validation processes, risk assessments, and process safety management activities.
Candidates must demonstrate strong project management skills to lead teams supporting product portfolios and ensure optimal production runs.
Matching Summary
Match Score: 85
The Lead Process Engineer at Merck & Co. is responsible for leading new product introductions and overseeing the transfer of drug products while providing technical support and guidance. The role requires advanced knowledge in pharmaceutical manufacturing processes, with a focus on continuous improvement and compliance.
Skills & Requirements
Must-have
5 years pharmaceutical manufacturing experience
Chemical or Mechanical Engineering degree
Process design and scale-up expertise
PPQ protocol authoring and execution
Root cause analysis and deviation management
GMP compliance and regulatory support
Technical leadership in product lifecycle
Nice-to-have
Advanced statistical analysis skills
Experience with sterile manufacturing boundaries
Strong project management capabilities
Global cross-site collaboration experience
Continuous process improvement mindset
EHS leadership behaviors
MPS (Our Production System) tools knowledge
Key Requirements
Bachelor's, Master's, or Ph.D. in Chemical Engineering, Mechanical Engineering, Chemistry, or Pharmaceutical Sciences
Minimum of 5 years of technical experience in pharmaceutical manufacturing industry