Senior Principal Engineer, Primary Container, Biologics
J&J FAMILY OF COMPANIES
Malvern, Pennsylvania, United States of America
Primary container system design and qualification
Global regulatory compliance fda ema ich
Container-closure integrity cci testing
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 container systems comply with rigorous global regulatory standards while driving innovation in drug delivery technologies like vials and pre-filled syringes.
Candidates must possess strong leadership skills to manage technical teams 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 and qualification
Global regulatory compliance FDA EMA ICH
Container-closure integrity CCI testing
Extractables and leachables E&L analysis
Biologics drug product development experience
Cross-functional team leadership and management
Regulatory submission documentation authoring
Nice-to-have
Pre-filled syringe system expertise
Aseptic processing knowledge
Sustainable packaging innovation
Lean supply chain management
Vendor relationship management
Continuous improvement initiatives
Patient usability focus
Key Requirements
Minimum 10 years experience in biologics or packaging science
Bachelor's degree in Pharmaceutics, Material Science, or related field
Proven leadership experience in pharmaceutical or biotech environments
Demonstrated experience with regulatory submissions (IND, BLA, NDA)
Strong understanding of combination product regulations and CMC expectations