Npi/tech Transfer Specialist

Merck Sharp & Dohme LLC

Rahway, New Jersey, US
Hybrid
Process, technical, and validation support
Analytical/engineering studies
Equipment qualification and validation
Merck Sharp & Dohme LLC is seeking a NPI/Tech Transfer Specialist to join their New Product Introductions Technical Engineering team in Rahway, New Jersey. The role emphasizes process, technical, and validation support for manufacturing processes and involves significant collaboration with cross-functional teams to ensure compliance and continuous improvement

Job Summary

  • Supporting New Product Introductions/Technical Transfers by providing process, technical, and validation support operations including ongoing support of manufacturing processes.
  • Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities, and coordination, design and execution of equipment qualification and validation.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities.

Matching Summary

Match Score: 85

Merck Sharp & Dohme LLC is seeking a NPI/Tech Transfer Specialist to join their New Product Introductions Technical Engineering team in Rahway, New Jersey. The role emphasizes process, technical, and validation support for manufacturing processes and involves significant collaboration with cross-functional teams to ensure compliance and continuous improvement.

Skills & Requirements

Must-have

  • Process, technical, and validation support
  • Analytical/engineering studies
  • Equipment qualification and validation
  • Process development studies
  • Root cause analysis of system failures
  • cGMP compliance

Nice-to-have

  • Lean Six Sigma methodologies
  • Cross functional team leadership
  • Global technical forums participation

Key Requirements

  • Bachelor’s Degree or higher preferred
  • Relevant experience in manufacturing, preferably GMP
  • Knowledge of regulatory/code requirements
  • Equipment and process validation experience
  • Sterile filling processes and equipment knowledge
  • Lean Six Sigma Methodology experience desired

Work Rights

Not specified

Tailored Resume

Cover Letter