Senior Principal Engineer, Primary Container, Biologics
Johnson & Johnson
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 requires deep technical expertise in container-closure integrity, extractables/leachables, and device-drug interface requirements to ensure patient safety and product stability.
Candidates must demonstrate strong leadership capabilities to manage a technical team, oversee complex project portfolios, and serve as a subject matter expert during regulatory inspections.
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 authoring IND BLA NDA
Nice-to-have
Pre-filled syringe system expertise
Sustainable packaging innovation
Lean supply chain management
Competitive landscape analysis
Advanced materials compatibility knowledge
Strategic problem-solving abilities
Vendor relationship management skills
Key Requirements
Minimum Bachelor's Degree in Pharmaceutics or related field
Minimum 10 years experience in biologics drug product development
Proven leadership experience in pharmaceutical or biotech environments
Demonstrated experience with pharmaceutics and regulatory submissions
Strong understanding of combination product regulations and CMC expectations