Engineer II, Process Equipment Engineer Small Molecule (Hopewell, NJ)

BeiGene•Hopewell, VA

2d•Onsite

About The Position

BeOne Medicines is seeking a highly motivated and organized engineer to join our team at the Hopewell, NJ site. The successful candidate will be 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 oral solid dose manufacturing including blending, granulation, compression and encapsulation. Projects may often require independent decision making and exercising judgment. This role will be based in Hopewell NJ and report to the Senior Director Engineering.

Requirements

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 and Capa management.
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.
Bachelor’s degree in Engineering, Life Sciences, or related field with 4+ years of GMP pharmaceutical experience required, or Masters degree with 2+ years required.
Experience with CMMS, Metrology, and facility maintenance is 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.

Nice To Haves

OE and/or LEAN Methodologies
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).

Responsibilities

Provide SME input into Equipment, Facility for Small Molecule project.
Provide SME input for the commissioning, qualification and validation of responsible systems.
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.
Manage the assets of buildings & facility.
Experience with small molecule drug product manufacturing equipment. With a focus on downstream equipment. For example, Tablet Press, Tablet Coating Machines, etc.
Solicit and respond to user input with the team members and maintain positive relationships with all internal and external stakeholders.
Directly support operations with troubleshooting and issue resolution with respect to equipment, facilities, and utilities.
Participate and lead in fault analysis and remediation.
Requires working in an industrial manufacturing environment including gowning.
Other duties as assigned.