Principal Engineer, Primary Container, Biologics

J&J FAMILY OF COMPANIES

Malvern, Pennsylvania, United States of America
Not specified; not specified; not specified
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 and operational excellence in packaging design.
  • Candidates must have proven leadership experience in pharmaceutical environments and demonstrate expertise in container-closure engineering and regulatory submissions.

Matching Summary

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

Salary

Not specified; Not specified; Not specified

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 collaboration skills
  • Innovation in emerging technologies
  • Continuous improvement mindset
  • Patient safety focus

Key Requirements

  • Minimum 8 years biologics packaging experience
  • Bachelor's degree in Pharmaceutics or Engineering
  • Advanced degree preferred
  • Proven leadership in pharma/biotech
  • Experience with IND BLA NDA submissions

Work Rights

Not specified

Tailored Resume

Cover Letter