Sr. Principal Engineer, Aseptic Dp Compounding Owner – Aseptic Dp Compounding

Johnson & Johnson

Wilson, North Carolina, United States of America
Fully remote
Aseptic biotherapeutic drug product compounding
Single-use technology design
Stainless steel tank design and cleaning
Johnson & Johnson is seeking a Sr. Principal Engineer for Aseptic Drug Product Compounding in Wilson, North Carolina. The ideal candidate will have extensive experience in aseptic drug product compounding within a biotherapeutics cGMP environment and will be responsible for leading process engineering initiatives and ensuring compliance with regulatory standards

Job Summary

  • The Sr. Principal Engineer will be the technical subject matter expert in aseptic, biotherapeutic drug product compounding, accountable for overall E2E process engineering leadership in the design and execution of implementing these areas.
  • Key responsibilities include developing equipment specifications, assessing vendor capabilities, leading detailed design and development of compounding suites, and managing commissioning and qualification activities.
  • This role requires a strong understanding of cGMPs, EHS requirements, single-use technology, and start-up processes, with a passion for solving highly complex technical problems.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Sr. Principal Engineer for Aseptic Drug Product Compounding in Wilson, North Carolina. The ideal candidate will have extensive experience in aseptic drug product compounding within a biotherapeutics cGMP environment and will be responsible for leading process engineering initiatives and ensuring compliance with regulatory standards.

Skills & Requirements

Must-have

  • Aseptic biotherapeutic drug product compounding
  • Single-use technology design
  • Stainless steel tank design and cleaning
  • Commissioning and Qualification (C&Q)
  • Technical subject matter expert (SME)

Nice-to-have

  • Partner management and leadership skills
  • Data-driven insights and market intelligence
  • Agile Decision Making
  • Cross-Functional Collaboration

Key Requirements

  • Minimum 10 years experience in aseptic drug product compounding
  • Bachelor's Degree in engineering (Chemical Engineering preferred)
  • Experience designing single-use technology
  • Experience designing stainless steel tanks and cleaning/sterilization recipes
  • Experience leading multicultural teams and remote customers

Work Rights

Not specified

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