Senior Engineer I, Drug Product Process Engineer (Hopewell, NJ)

BeOne Medicines; Hopewell (NJ); On-site; USD 109,900 - 149,900; Full time

Benefits offered by this job

Comprehensive benefits package

Annual bonus plan

Employee Stock Purchase Plan

Job summary

BeOne Medicines in Hopewell, NJ, is looking for a highly motivated Drug Product Process Engineer. This role involves maintaining the Fill Finish line and providing engineering services for projects while working independently.

The successful candidate will be responsible for supporting technology transfer, developing technical documentation, and troubleshooting operations issues. A BS degree in engineering or related field and 5+ years of experience in biopharmaceutical manufacturing are required.

Qualifications

• Minimum 5 years of experience in biopharmaceutical manufacturing and engineering.
• Proven ability to manage multiple complex priorities simultaneously.
• Prior hands-on experience in drug product production systems.

Responsibilities

• Support technology transfer and qualification studies for drug product manufacturing.
• Develop and review technical documentation.
• Directly support operations with troubleshooting and issue resolution.

Skills

Analytical problem-solving skills

Project Management

Technical direction

Collaboration with Operations and Quality

Education

BS or higher in engineering and/or related discipline

Tools

Microsoft Project

Autocad

Smartsheet

Job 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.

General Description

BeOne Medicines is seeking a highly motivated and organized Drug Product Process Engineer to join our team at the Hopewell, NJ site. The successful candidate will be responsible for maintaining the Fill Finish line and providing engineering services to assigned projects and troubleshooting. This role works independently, with minimal supervision and direction and will provide technical direction, Project Management support, Commissioning and SME expertise in the areas of Facility, Utility and Metrology, instrumentation /control services. Projects may often require independent decision making and exercising judgment.

Responsibilities

• Support of technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to drug product manufacturing.
• Partner with Operations, Quality, and Automation functional areas on validation studies in support of GMP process equipment (IQ/OQ/PQ), cleaning (CIP, COP), Sanitization and Sterilization (SIP, autoclave, depyrogenation, VHP).
• Develop and review technical documentation.
• Participate and lead in controls fault analysis and remediation.
• Directly support operations with troubleshooting and issue resolution.
• Work on small cross functional teams in support of small projects or initiatives.
• Require working in an industrial manufacturing environment including gowning.
• Support operations and ensure compliance with regulatory, corporate and site requirements.
• Operate self‑sufficiently and motivate oneself; develop and maintain transparent communication between departments.

Required Education/Experience

• BS or higher in engineering and/or related discipline.
• Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or project management and at least 3 years of project management experience in biologics or GMP.
• Minimum of 5 years of GMP pharmaceutical operations support.
• Proven ability to manage multiple complex priorities simultaneously under tight timelines.
• Analytical problem‑solving skills and proactive decision‑making.
• Ability to summarize and present project information clearly to management.
• Prior hands‑on experience in the design, selection, and troubleshooting of systems and equipment used in commercial drug product production is required (e.g., Lyophilizers, isolators, aseptic/sterile filling machines).
• Experience with production support equipment: parts washers, autoclaves, etc. is preferred.

Preferred Skills/Experience

• OE and/or LEAN Methodologies.

Physical Requirements

• Ability to work in an office environment, construction site, and laboratory or manufacturing areas.
• May require up to 5% travel, including visits to partner or manufacturing sites.
• Must be able to sit, stand, and use standard office equipment for extended periods.

Computer Skills

• Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
• Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.
• Familiarity with data management and visualization tools (e.g., SharePoint, Teams, Power BI).
• Ability to create and maintain Gantt charts, dashboards, and tracking templates.
• Comfortable working within document management systems (e.g., Veeva Vault, eQMS, or similar).

Travel

May require domestic travel up to 5%.

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 - $149,900.00 annually

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job‑related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non‑Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Equal Opportunity Statement

We are 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].