Senior Engineer I, Drug Product Process Engineer (Hopewell, NJ)
BeiGene
Hopewell, Virginia
Full-Time
$109,900
OfficeSenior
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
Requires working in an industrial manufacturing environment including gowning
Support operations and ensure compliance with regulatory, corporate and site requirements
The ability to operate self-sufficiently and to motivate oneself is crucial for the success of this position. In addition, the ability for this person to develop and maintain transparent communication between departments is essential
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. This includes experience working with Lyophilizers, isolators, aseptic/sterile filling machines, etc.
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% travel
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
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.
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 accommodationsus@beonemed.com.