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

BeiGene•Hopewell, NJ

1d•$109,900 - $149,900•Onsite

About The Position

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.

Requirements

BS or higher in engineering and/or related discipline.
Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or project management
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.
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
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).

Nice To Haves

Experience with production support equipment: parts washers, autoclaves, etc. is preferred.
OE and/or LEAN Methodologies
Experience with project management tools such as Microsoft Project, Autocad, Smartsheet.

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