Principal Engineer, Primary Container, Biologics

Johnson & Johnson

Malvern, Pennsylvania, United States of America
Primary container system development
Biologics drug product packaging
Global regulatory compliance fda ema
The Principal Engineer will lead the global strategy for primary containers supporting biologics across the Johnson & Johnson Innovative Medicine portfolio

Job Summary

  • The Principal Engineer will lead the global strategy for primary containers supporting biologics across the Johnson & Johnson Innovative Medicine portfolio.
  • This role ensures all primary containers comply with global regulatory requirements while driving innovation in container technologies and operational excellence.
  • Candidates must provide technical leadership on container-closure integrity, extractables and leachables, and materials compatibility to support formulation stability and patient usability.

Matching Summary

The Principal Engineer will lead the global strategy for primary containers supporting biologics across the Johnson & Johnson Innovative Medicine portfolio.

Skills & Requirements

Must-have

  • Primary container system development
  • Biologics drug product packaging
  • Global regulatory compliance FDA EMA
  • Container closure integrity testing
  • Extractables and leachables analysis
  • Vendor relationship management

Nice-to-have

  • Strategic leadership in supply chain
  • Cross-functional team collaboration
  • Continuous improvement innovation
  • Patient safety focus
  • Complex portfolio management

Key Requirements

  • Minimum 8 years experience in biologics packaging
  • Bachelor's degree in Pharmaceutics or Engineering
  • Proven leadership in pharmaceutical environments
  • Experience with IND BLA NDA submissions
  • Expertise in combination product regulations

Work Rights

Not specified

Tailored Resume

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