B

BeOne

Global oncology therapeutics discovery, development, manufacturing

Engineer 2 - Process Equipment Engineer Small Molecule

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeHopewell, NJ, USA$95.6k - $130.6k /yr

About the Job

Requirements

  • A bachelor's degree in Engineering, Life Sciences, or a related field with at least 4 years of GMP pharmaceutical experience, or a master's degree with at least 2 years of experience, is required.
  • At least 4 years of experience supporting GMP facilities or maintenance, or working in operations, is required.
  • At least 4 years of equipment and facility support in a GMP environment is required, along with a strong understanding of quality in GMP environments, including Good Documentation Practices, deviation management, and CAPA management.
  • Experience with CMMS, metrology, and facility maintenance is required.
  • Experience with small molecule drug product manufacturing equipment, especially downstream equipment such as tablet presses and tablet coating machines, is required.
  • Experience serving as a subject matter expert for equipment input is required.
  • Experience in process engineering for small molecule projects is required.
  • People leadership and direct supervision are required.
  • Ability to work in an industrial manufacturing environment, including gowning, is required.
  • Ability to work in an office environment, construction site, and laboratory or manufacturing areas is required.
  • Ability to sit, stand, and use standard office equipment for extended periods is required.
  • Proficiency with Microsoft Office Suite, including Excel, PowerPoint, Word, and Outlook, is required.
  • Ability to create and maintain Gantt charts, dashboards, and tracking templates is required.
  • Familiarity with data management and visualization tools, including SharePoint, Teams, and Power BI, is required.
  • Comfort working within document management systems such as Veeva Vault, eQMS, or similar is required.
  • Ability to work self-sufficiently and maintain transparent communication between departments is required.
  • Ability to travel domestically up to 5% may be required.

Responsibilities

  • Support a new small molecule manufacturing facility and maintain a stable, qualified, GMP manufacturing facility in collaboration with manufacturing and quality teams.
  • Ensure reliable operation and compliance of a 24x7 commercial manufacturing facility.
  • Provide technical direction, project management support, commissioning expertise, and subject matter expertise in oral solid dose manufacturing, including blending, granulation, compression, and encapsulation.
  • Provide subject matter expert input into equipment and facility for the small molecule project.
  • Provide subject matter expert input for commissioning, qualification, and validation of responsible systems.
  • Develop and maintain technical and operational procedures and preventive maintenance plans for responsible systems.
  • Work with the Global Engineering cross-functional team to achieve project milestones and key performance indicators.
  • Work with external partners as required.
  • Manage building and facility assets.
  • Solicit and respond to user input with team members and maintain positive relationships with internal and external stakeholders.
  • Directly support operations by troubleshooting and resolving issues related to equipment, facilities, and utilities.
  • Participate in and lead fault analysis and remediation.
  • Perform other duties as assigned.
  • Present project information clearly to management.

Desired Qualifications

  • Experience with operational excellence and/or LEAN methodologies is preferred.
  • Proficiency with Maximo is preferred.
  • Experience with project management tools such as Microsoft Project, AutoCAD, and Smartsheet is preferred.

About the Company

BeOne

Global oncology therapeutics discovery, development, manufacturing

BeOne Medicines discovers, develops, and commercializes oncology therapies worldwide, focusing on hematologic cancers and solid tumors. Its products work by leveraging internal R&D and clinical development to bring therapies to market quickly, with Brukinsa serving as a leading backbone in the US and European markets. It differentiates itself through a large-scale global clinical network and cost-efficient development and manufacturing that support high margins and a focus on large-market cancer indications. Its goal is to expand access to high-impact, affordable cancer treatments across more than 45 countries while growing its pipeline into immunology and solid tumors.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Dongcheng District, China
Founded
2010

Recently Posted Jobs

Explore more opportunities at BeOne

See more jobs