Principal Engineer, Primary Container, Biologics

Johnson & Johnson Innovative Medicine•Malvern, PA

5d•Onsite

About The Position

The Principal Engineer Primary Container, Biologics, 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. The role ensures all primary containers comply with global regulatory, technical, and quality standards while driving innovation and operational excellence. This position is part of the global Drug Delivery Systems (DDS) Team and reports to the Global Head Drug Delivery Systems.

Requirements

Minimum of Bachelor's Degree in Pharmaceutics, Material Science, Biomedical Engineering, Chemical Engineering, or a related field is required.
Minimum of 8 years of experience in biologics drug product development, packaging science, or container–closure engineering is required.
Proven leadership experience in pharmaceutical or biotech environments is required.
Demonstrated experience with pharmaceuticals and regulatory submissions is required.
Strong understanding of combination product regulations and CMC expectations is required.

Nice To Haves

Advanced degree is preferred.
Expertise in CCI testing, extractables/leachables, materials compatibility, and aseptic processing is preferred.
Specific expertise in pre-filled syringe systems is preferred.

Responsibilities

Define and implement 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.
Oversee the design, evaluation, and qualification of primary container systems including vials, pre-filled syringes, cartridges, stoppers, and seals.
Provide scientific leadership on container–closure integrity (CCI), extractables and leachables (E&L), materials compatibility, and device-drug interface requirements.
Ensure container strategies support formulation stability, manufacturability, and patient usability.
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.
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.