Qualifications
Responsibilities
Benefits
General Description:
BeOne Medicines is seeking highly motivated and organized engineer, to join our team at the Hopewell, NJ site. The successful candidate willbe responsible for supporting a new Small Molecule manufacturing facility and maintaining a stable, qualified, GMP manufacturing facility in close collaboration with the manufacturing and quality teams. The individual ensures reliable operation and state of compliance for a 24x7 commercial manufacturing facility. 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 utilities equipment supporting the small molecule drug product manufacturing facility and equipment. This role will be based in Hopewell NJ.
Responsibilities:
Provide SME input into Utilities and Facility for Small Molecule project.
Provide SME input for the commissioning, qualification and validation of responsible systems.
Start-up, troubleshoot and manage the clean and black utility equipment supporting the small molecule drug product manufacturing facility.
Develop and maintain technical, operational procedures, preventative maintenance plans for responsible systems.
Work in cross functional team with Global Engineering to hit project milestones and KPIs.
Work with external partners as required.
Collaborate with the team members and develop positive relationships with all internal and external stakeholders.
Directly support manufacturing operations with respect to equipment, facilities, and utilities.
Requires working in an industrial manufacturing environment including gowning.
Other duties as assigned.
Required Skills/Experience:
BS or higher in engineering and/or related discipline.
Minimum of 4 + years of equipment and facility support in a GMP environment. Strong understanding of Quality in GMP environment including Good Documentation Practices, Deviation, Change Control and CAPA management.
Strong knowledge of HVAC, Process Water, Chilled Water, Process Gases, Dust Collection and other utility equipment supporting small molecule drug product manufacturing facility.
Excellent communication and interpersonal skills, with the ability to collaborate across functional teams.
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.
Bachelors degree in Engineering, Life Sciences, or related field with 4+ years of GMP pharmaceutical experience required, or Masters degree with 2+ years required.
People leadership, direct supervision required.
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.
Preferred Skills/Experience
Technical writing
OE and/or LEAN Methodologies
Physical Requirements:
Ability to work in an office environment, construction site, and laboratory or manufacturing areas.
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).
Proficiency with CMMS, Maximo preferred.
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).
Other Qualifications: Demonstrates strong accountability, communication, and ability to build trust in a fast-paced, regulated environment
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.
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