Senior Packaging Engineer (Hopewell, NJ)

General Description BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. As part of the Manufacturing Science and Technology (MST) group, the Senior Packaging Engineer will provide life‑cycle validation technical support for the Oral Solid Dose (OSD) packaging operation at the Hopewell, NJ manufacturing site. Starting with Technology Transfer, this position will support equipment installation and start‑up and ensure site readiness for Process Performance Qualification (PPQ) as well as Continued Process Verification (CPV). The engineer will serve as the site Packaging SME and primary liaison with the Global Packaging Engineering & Artwork group to uphold company standards and packaging practices. They will provide technical support for packaging operations, collaborating cross‑functionally with operations, quality, supply chain, commercial, regulatory, finance, and other BeOne teams to commercialize products that create a successful patient experience. The role includes managing site material specifications and the Bill of Materials (BOM) and ensuring all packaging systems, equipment and processes comply with global regulatory requirements (e.g., FDA, EMA). Essential Functions of the Job Manage site‑level change controls in alignment with packaging components and artwork changes. Review and approve packaging batch records as the technical owner. Support development of the technology transfer plan and author validation protocols and reports. Develop and implement continuous process verification programs. Support authoring for regulatory submissions. Lead complex investigations, perform root‑cause analysis, and implement corrective and preventive actions (CAPAs). Provide technical support for ongoing packaging activities at the Hopewell site, including process troubleshooting and support for new equipment initiatives. Author regulatory documents in support of product applications or provide regulatory filing and submission support. Education and Experience Required Bachelor’s degree and at least 4+ years of engineering experience (required). Master’s degree and at least 2+ years of engineering experience (preferred). Supervisory Responsibilities No direct reports, but the engineer will lead cross‑functional teams. Computer Skills Proficient in Microsoft Office applications (Word, Excel, Outlook), ERP systems (SAP preferred). Other Qualifications Familiarity with global pharmaceutical regulatory requirements (e.g., GMP, GDP). Experience leading teams, projects, or programs and directing resource allocation, preferably within the biotech, pharmaceutical, CRO, or industry sectors. Availability for early morning or evening global meetings. Travel Less than 10% global travel. Global Competencies Fosters teamwork. Provides and solicits honest and actionable feedback. Self‑awareness. Acts inclusively. Demonstrates initiative. Entrepreneurial mindset. Continuous learning. Embraces change. Results‑oriented analytical thinking/data analysis. Financial excellence. Communicates with clarity. Salary Range $109,900.00 – $144,900.00 annually. Benefits The Company offers a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness programs. Equal Opportunity Employer BeOne is proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state, or local laws, applicants who require reasonable accommodation in the job application process may contact View email address on click.appcast.io. #J-18808-Ljbffr