Principal Engineer, Primary Container, Biologics
<p style="text-align:left !important">At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at <a target="_blank" href="https://www.jnj.com."><span style="color:#0000ff"><u>jnj.com</u></span></a>.</p><p></p><p>As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p></p><p></p><p style="text-align:left"><b><span><span>Job Function: </span></span></b></p>Supply Chain Engineering<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Packaging Design Engineering<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Category:</b></p>Scientific/Technology<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>All Job Posting Locations:</b></p>Malvern, Pennsylvania, United States of America<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Job Description:</b></p><p><b>About Innovative Medicine </b></p><p>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.</p><p>Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.</p><p>Learn more at https://www.jnj.com/innovative-medicine</p><p></p><p><b>We are searching for the best talent for Principal Engineer, Primary Container, Biologics in Malvern, PA.</b></p><p></p><p><b>Purpose:</b> 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. The location for this position is Malvern, PA (US). It is part of the global Drug Delivery Systems (DDS) Team. The position reports to the Global Head Drug Delivery Systems.</p><p></p><p><b>You will be responsible for:</b></p><p><b>Strategic Leadership & Governance</b></p><ul><li>Define and implement the global strategy for primary containers supporting biologics across the JJIM portfolio.</li></ul><p></p><ul><li>Oversee development, qualification, and lifecycle management of vial systems, pre-filled syringes, cartridges, and new container technologies.</li></ul><p></p><ul><li>Ensure compliance with global regulatory requirements and internal quality standards.</li></ul><p></p><ul><li>Partner with cross-functional teams (R&D, Quality, Regulatory, Supply Chain) to align container solutions with product needs.</li></ul><p></p><ul><li>Lead risk assessments and mitigation strategies for container systems.</li></ul><p></p><ul><li>Manage vendor relationships and evaluate new technologies to enhance performance and patient safety.</li></ul><p></p><ul><li>Provide technical leadership and subject matter expertise for regulatory submissions and inspections.</li></ul><p></p><ul><li>Drive innovation and the implementation of new technologies across biologics packaging.</li></ul><p></p><ul><li>Drive continuous improvement and innovation in container technologies.</li></ul><p></p><p><b>Technical Expertise & Development</b></p><ul><li>Oversee the design, evaluation, and qualification of primary container systems including vials, pre-filled syringes, cartridges, stoppers, and seals.</li></ul><p></p><ul><li>Provide scientific leadership on container–closure integrity (CCI), extractables and leachables (E&L), materials compatibility, and device-drug interface requirements.</li></ul><p></p><ul><li>Ensure container strategies support formulation stability, manufacturability, and patient usability.</li></ul><p></p><p><b>Project & Portfolio Management</b></p><ul><li>Partner across CMC, Formulation, Device Engineering, Quality, and Manufacturing to drive product development programs.</li></ul><p></p><ul><li>Manage timelines, resources, and budgets for container-related activities.</li></ul><p></p><ul><li>Lead risk assessments, mitigation strategies, and governance reviews.</li></ul><p></p><p><b>Regulatory & Compliance</b></p><ul><li>Ensure compliance with global regulatory expectations (FDA, EMA, ICH, ISO, USP/EP/JP).</li></ul><p></p><ul><li>Author and review regulatory documentation for IND, IMPD, BLA, and NDA submissions.</li></ul><p></p><ul><li>Serve as SME during regulatory inspections and health authority interactions.</li></ul><p></p><p><b>Qualifications/Requirements:</b></p><p></p><p><b>Education:</b> Minimum of Bachelor's Degree in Pharmaceutics, Material Science, Biomedical Engineering, Chemical Engineering, or a related field is required. Advanced degree is preferred.</p><p><b>Skills/Experience:</b></p><ul><li>Minimum of 8 years of experience in biologics drug product development, packaging science, or container–closure engineering is required.</li></ul><p></p><ul><li>Proven leadership experience in pharmaceutical or biotech environments is required.</li></ul><p></p><ul><li>Demonstrated experience with pharmaceuticals and regulatory submissions is required.</li></ul><p></p><p><b>Technical Skills</b></p><ul><li>Expertise in CCI testing, extractables/leachables, materials compatibility, and aseptic processing is preferred.</li></ul><p></p><ul><li>Strong understanding of combination product regulations and CMC expectations is required.</li></ul><p></p><ul><li>Specific expertise in pre-filled syringe systems is preferred.</li></ul><p></p><p><b>Leadership & Soft Skills</b></p><ul><li>Strong leadership, team-building, and cross-functional collaboration skills.</li></ul><p></p><ul><li>Excellent communication and strategic problem‑solving abilities.</li></ul><p></p><ul><li>Ability to manage complex portfolios with multiple competing priorities.</li></ul><p></p><p></p><p>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. </p><p></p><p>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 <a href="https://www.jnj.com/contact-us/careers" target="_blank">https://www.jnj.com/contact-us/careers</a> , internal employees contact AskGS to be directed to your accommodation resource.</p><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p> </p><p> </p><p><b>Required Skills: </b></p><p> </p><p> </p><p><b>Preferred Skills:</b></p>Coaching, Competitive Landscape Analysis, Critical Thinking, EHS Compliance, Engineering, Good Manufacturing Practices (GMP), Lean Supply Chain Management, Organizing, Package and Labeling Regulations, Package Management, Process Improvements, Product Packaging Design, Science, Technology, Engineering, and Math (STEM) Application, Standard Operating Procedure (SOP), Sustainability, Sustainable Packaging, Transparency Reporting, Validation Testing
