Senior Shipping Validation Engineer II, Drug Product Development

Serve as the technical lead and subject matter expert for shipping validation within Drug Product Development.,Define and implement robust, risk-based validation strategies across temperature-controlled distribution systems.,Design, qualify, and maintain global shipping systems supporting clinical and commercial product movement.,Execute distribution and packaging studies including temperature mapping, ISO/ASTM testing, and thermal modeling.,Lead lane qualification and lifecycle management activities across validated transport solutions.,Drive strategic decision-making through risk assessments, data analysis, and regulatory compliance frameworks.,Author, review, and approve technical documents including validation master plans, protocols, and SOPs.,Support internal and external audits, including health authority inspections and responses.,Lead investigations, CAPAs, and change controls related to shipping systems and temperature excursions.,Collaborate with Quality, Regulatory, Supply Chain, and Engineering to align and execute shipping strategies for late-stage and commercial programs.,Contribute to global regulatory submissions, including INDs, BLAs, and MAAs, by authoring distribution-related sections.,Provide mentorship to junior engineers in validation strategy, technical documentation, and compliance standards.,Advance platform-level initiatives by developing scalable validation approaches and contributing to organizational best practices.

Degree in Chemical/Mechanical/Packaging/Biomedical Engineering, Pharmaceutical Sciences, or related discipline.,Minimum of 4 years (PhD), 8 years (MS), or 10 years (BS) of industry experience in biopharmaceutical development, focused on shipping validation.,Experience working closely with external CDMOs and service providers.,Experience in shipping of parenteral Drug Products and commercialization of a range of relevant drug product images such as pre-filled syringes, injection devices and vials.,Knowledge and understanding of product/packaging interaction, barrier properties, stability, global pharmaceutical shipping regulations, and distribution testing.,Ability to work independently as well as part of a team in a highly dynamic, fast-paced, matrixed environment with rapidly evolving priorities.,Ability to travel up to 20%.

Degree in Chemical/Mechanical/Packaging/Biomedical Engineering, Pharmaceutical Sciences, or related discipline (Bachelor's, Master's, or PhD)

Must be willing to travel up to 20%.,Requires U.S. person status (citizens, permanent residents, asylees, or refugees) due to export control laws.,This position is site-based and not eligible for remote work.