**General Description:** Supporting Product commercialization for BeOne, the Senior Manager Packaging Engineering will have a main focus on our Hopewell, NJ manufacturing site, and responsible for commercial packaging qualification for drug substance, drug product, primary container/closure and final product presentations by: + Utilization of standard processes in commercial development and lifecycle management of BeOne products in alignment with the overall manufacturing/packaging capability of BeOne operations at the Hopewell site as well as globally. + Serving as the technical packaging lead in cross-functional teams including packaging site, supply chain, commercial, regulatory, finance, clinical, quality as well as across BeOne to commercialize products that create a successful patient experience. + Assisting in the development of annual goals and strategic direction for the packaging organization aligning with the company overall strategy. + Supporting product launches, tech transfers, and global expansion initiatives at our Hopewell site with packaging expertise. + Ensure all packaging systems, equipment and processes comply with global regulatory requirements (e.g., FDA, EMA, etc.). **Essential Functions of the Job:** + Technical Support for the BeOne Hopewell, NJ, directing the design, supporting process, qualification, documentation and implementation of commercial packaging and thermal shipping solutions aligning with the product strategy including: + Manage package development documents (technical drawing, specification, technical assessment, development protocol and report) utilizing the Veeva system. + Develop and execute risk assessment, qualification plan, protocol, and summary report related to component qualification, packaging line testing, and temperature-controlled shipping system. + Support HPW site in commercial launch and after launch efforts, packaging line qualification, pack design and specification, artwork, MBR development, process improvement, and troubleshooting. + Technical support for ongoing packaging activities at the Hopewell site, including process troubleshooting and support for new equipment initiatives. + The pursuit of packaging technologies that will drive innovation and gain efficiency in packaging operations. + Lead commercial packaging engineering activities in market launches and projects to meet predefined timeline and budget. + Manage and execute change controls and deviations related to packaging. + Author regulatory documents in support of product applications or provide regulatory filing and submission support. + Accomplish goals within a team first environment and with respect for all members. + Deliver progress reports and presentations ensuring that management is aware of the current status, progress, and future needs of projects and the organization. + Identify and ensure area of responsibility complies with the most current standards and company policies. **Education and Experience Required:** + Bachelor's degree or and 7 years of Engineering experience or Master's degree and 5 years of Engineering experience, + Demonstrated experience leading teams, projects, programs or directing the allocation of resources preferably within the biotech, pharmaceutical, CRO, industry. **Supervisory Responsibilities:** + Possibly intern supervision **Computer Skills:** Proficient in Microsoft Office applications (Word, Excel, and Outlook), ERP Systems. **Other Qualifications:** Understands comprehensive global pharmaceutical regulatory requirements (e.g. GMP, GDP). Due to global nature of company early morning or evening meetings may be required. **Travel:** Up to 20% All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.