Principal Engineer, Primary Container, Biologics

Johnson & Johnson Innovative Medicine

Malvern, Pennsylvania, United States
Not specified (assumed to be on-site due to location mention)
Primary container development
Biologics drug product development
Container-closure integrity
Johnson & Johnson is seeking a Principal Engineer for Primary Container, Biologics to lead the development and lifecycle management of packaging systems for biologic drug products. The role emphasizes innovation, compliance with regulatory standards, and collaboration across functions in the healthcare sector

Job Summary

  • The Principal Engineer Primary Container, Biologics will lead the development, selection, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and emerging container technologies for new biologic drug products.
  • This role ensures all primary containers comply with global regulatory, technical, and quality standards while driving innovation and operational excellence.
  • You will partner across CMC, Formulation, Device Engineering, Quality, and Manufacturing to drive product development programs and manage timelines, resources, and budgets for container-related activities.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Principal Engineer for Primary Container, Biologics to lead the development and lifecycle management of packaging systems for biologic drug products. The role emphasizes innovation, compliance with regulatory standards, and collaboration across functions in the healthcare sector.

Skills & Requirements

Must-have

  • primary container development
  • biologics drug product development
  • container-closure integrity
  • extractables and leachables
  • pharmaceutical regulatory submissions

Nice-to-have

  • strategic problem-solving abilities
  • team-building skills
  • patient safety focus
  • operational excellence

Key Requirements

  • Bachelor's Degree required
  • 8+ years experience required
  • Proven leadership experience required
  • Demonstrated pharmaceutical regulatory submissions experience required
  • Strong understanding of combination product regulations required

Work Rights

Not specified

Tailored Resume

Cover Letter