Senior Principal Engineer, Primary Container, Biologics
Johnson & Johnson
Malvern, Pennsylvania, United States of America
Primary container system design
Biologics drug product development
Global regulatory compliance
The Senior Principal Engineer will lead the global strategy for primary containers supporting biologics across the Johnson & Johnson Innovative Medicine portfolio
Job Summary
The Senior 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 vial systems, pre-filled syringes, and cartridges.
Candidates must possess strong leadership skills to manage a technical team and partner with cross-functional groups including R&D, Quality, and Regulatory affairs.
Matching Summary
The Senior 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 design
Biologics drug product development
Global regulatory compliance
Container-closure integrity testing
Extractables and leachables analysis
Cross-functional team leadership
Regulatory submission authoring
Nice-to-have
Pre-filled syringe system expertise
Aseptic processing knowledge
Sustainable packaging initiatives
Lean supply chain management
Vendor relationship management
Continuous improvement strategies
Patient usability focus
Key Requirements
Minimum 10 years experience in biologics packaging
Bachelor's degree in Pharmaceutics or related field
Proven leadership in pharmaceutical environments
Demonstrated experience with regulatory submissions