Senior Packaging Engineer (Hopewell, NJ)

BeiGene, Ltd.; Hopewell (VA); On-site; USD 109,900 - 144,900; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

401(k) plan

Paid Time Off

Wellness programs

Job summary

BeiGene, Ltd. is seeking a Senior Packaging Engineer at their Hopewell, NJ site. The engineer will provide lifecycle validation support for the Oral Solid Dose packaging operation and manage packaging specifications. Responsibilities include overseeing change controls, reviewing batch records, and ensuring compliance with global regulations.

The position requires a Bachelor’s degree in engineering and at least four years of relevant experience. This role offers a salary range of $109,900 to $144,900 annually along with comprehensive benefits.

Qualifications

• Bachelor’s degree in engineering is mandatory.
• 4+ years of engineering experience is required.
• Master’s degree and 2+ years of engineering experience preferred.

Responsibilities

• Manage site-level change controls for packaging.
• Review and approve packaging batch records.
• Support technology transfer and validation protocols.
• Lead investigations and implement corrective actions.

Skills

Engineering experience

Validation protocols

Regulatory compliance

Cross-functional collaboration

Microsoft Office proficiency

Project leadership

Education

Bachelor’s degree in engineering

Master’s degree in engineering

Tools

SAP

Job description

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 [e-mail].