Senior Engineer, Primary Container, Biologics

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for Senior Engineer Primary Container Biologics in Malvern PA.

Purpose: The Senior Engineer Primary Container Biologics will lead the development selection qualification and lifecycle management of vial systems pre-filled syringes cartridges cell therapy bags and emerging container technologies for new biologic drug products. The role ensures all primary containers comply with global regulatory technical and quality standards while driving innovation and operational excellence. It is part of the global Drug Delivery Systems (DDS) Team.

You will be responsible for:

Strategic Leadership & Governance

• Execute the global strategy for primary containers supporting biologics across the JJIM portfolio.
• Oversee development qualification and lifecycle management of vial systems pre-filled syringes cartridges and new container technologies.
• Ensure compliance with global regulatory requirements and internal quality standards.
• Partner with cross-functional teams (R&D Quality Regulatory Supply Chain) to align container solutions with product needs.
• Lead risk assessments and mitigation strategies for container systems.
• Manage vendor relationships and evaluate new technologies to enhance performance and patient safety.
• Provide technical leadership and subject matter expertise for regulatory submissions and inspections.
• Drive innovation and the implementation of new technologies across biologics packaging.
• Drive continuous improvement and innovation in container technologies.

Technical Expertise & Development

• Support the development of advanced therapy packaging including cell therapy bags and cryo-capable container closure systems.
• Oversee the design evaluation and qualification of primary container systems including vials pre-filled syringes cartridges stoppers and seals.
• Provide scientific leadership on containerclosure integrity (CCI) extractables and leachables (E&L) materials compatibility and device-drug interface requirements.
• Ensure container strategies support formulation stability manufacturability and patient usability.

Project & Portfolio Management

• Partner across CMC Formulation Device Engineering Quality and Manufacturing to drive product development programs.
• Manage timelines resources and budgets for container-related activities.
• Lead risk assessments mitigation strategies and governance reviews.

Regulatory & Compliance

• Ensure compliance with global regulatory expectations (FDA EMA ICH ISO USP/EP/JP).
• Author and review regulatory documentation for IND IMPD BLA and NDA submissions.
• Serve as SME during regulatory inspections and health authority interactions.

Qualifications/Requirements:

Education: Minimum of a Bachelors Degree in Packaging Engineering Material Science Biomedical Engineering Chemical Engineering or a related field is required. Advanced degree is preferred.

Experience/Skills:

• Minimum of 5 years of experience in biologics drug product development packaging science or containerclosure engineering.
• Proven leadership experience in pharmaceutical or biotech environments.
• Demonstrated experience with commercial biologics and regulatory submissions.

Technical Skills

• Expertise in CCI testing extractables/leachables materials compatibility and aseptic processing.
• Strong understanding of combination product regulations and CMC expectations.
• Specific expertise in pre-filled syringe systems is preferred.

Leadership & Soft Skills

• Strong leadership team-building and cross-functional collaboration skills.
• Excellent communication and strategic problemsolving abilities.
• Ability to manage complex portfolios with multiple competing priorities.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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