Senior Principal Engineer, Primary Container, Biologics

Johnson & Johnson

Malvern, Pennsylvania, United States of America
Primary container system development
Global regulatory compliance
Biologics drug product packaging
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

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 within the global Drug Delivery Systems Team.
  • Johnson & Johnson provides an inclusive work environment that respects diversity and dignity, actively seeking qualified candidates who are protected veterans and individuals with disabilities.

Matching 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.

Skills & Requirements

Must-have

  • Primary container system development
  • Global regulatory compliance
  • Biologics drug product packaging
  • Cross-functional team leadership
  • Container–closure integrity expertise
  • Risk assessment and mitigation
  • Technical team management

Nice-to-have

  • Innovation in container technologies
  • Strong communication skills
  • Strategic problem-solving abilities
  • Experience with pre-filled syringe systems
  • Collaboration across R&D and Quality
  • Continuous improvement mindset

Key Requirements

  • Minimum Bachelor's Degree in relevant field
  • At least 10 years experience in biologics drug product development
  • Proven leadership in pharmaceutical or biotech environments
  • Experience with pharmaceutics and regulatory submissions
  • Knowledge of FDA, EMA, ICH, ISO regulations

Work Rights

Not specified

Tailored Resume

Cover Letter