Senior Principal Engineer, Primary Container, Biologics

Johnson & Johnson MedTech

Malvern, Pennsylvania, United States
Not specified
Primary container systems development
Global regulatory compliance
Container–closure integrity expertise
Johnson & Johnson MedTech is seeking a Senior Principal Engineer for Primary Container, Biologics, to lead the development and lifecycle management of container technologies for biologic drug products. The ideal candidate will possess extensive experience in biologics packaging and strong leadership skills, ensuring compliance with regulatory standards and driving innovation in container systems

Job Summary

  • The Senior Principal Engineer 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.
  • Johnson & Johnson provides an inclusive work environment respecting diversity and dignity, actively supporting protected veterans and individuals with disabilities.

Matching Summary

Match Score: 85

Johnson & Johnson MedTech is seeking a Senior Principal Engineer for Primary Container, Biologics, to lead the development and lifecycle management of container technologies for biologic drug products. The ideal candidate will possess extensive experience in biologics packaging and strong leadership skills, ensuring compliance with regulatory standards and driving innovation in container systems.

Skills & Requirements

Must-have

  • Primary container systems development
  • Global regulatory compliance
  • Container–closure integrity expertise
  • Cross-functional team leadership
  • Risk assessment and mitigation
  • Lifecycle management of vial systems

Nice-to-have

  • Strong communication skills
  • Strategic problem-solving abilities
  • Innovation in container technologies
  • Vendor relationship management
  • Team-building and collaboration

Key Requirements

  • Minimum 10 years biologics drug product experience
  • Bachelor's degree in related engineering or science field
  • Proven pharmaceutical or biotech leadership
  • Experience with pharmaceutics and regulatory submissions
  • Knowledge of FDA, EMA, ICH, ISO regulations

Work Rights

Not specified

Tailored Resume

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