BeOne
biopharmaceutical
SeniorEngineerI,DrugProductProcessEngineer
“Senior Engineer I, Drug Product Process Engineer at BeOne. Skills: Drug Product Process Engineering, Fill Finish line maintenance, engineering services, troubleshooting, technical direction, Project Management support, Commissioning, SME expertise, Facility, Utility, Metrology, instrumentation /control services, technology transfer, validation studies, GMP process equipment (IQ/OQ/PQ), cleaning (CIP, COP), Sanitization, Sterilization (SIP, autoclave, depyrogenation, VHP). maintaining the Fill Fi”
What You'll Achieve.
Results-Oriented
Industry & Context.
Analytical problem-solving skills; proactive decision-making; troubleshooting; controls fault analysis; Analytical Thinking/Data Analysis
Requires working in an industrial manufacturing environment including gowning, 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
What They're Looking For.
Must Have
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, Experience working with Lyophilizers, isolators, aseptic/sterile filling machines, Ability to operate self-sufficiently, Ability to motivate oneself, Ability to develop and maintain transparent communication between departments
Nice to Have
Experience with production support equipment: parts washers, autoclaves, OE and/or LEAN Methodologies
What You'll Do.
maintaining the Fill Finish line
providing engineering services to assigned projects
Support of technology transfer and qualification studies associated with the development and implementation of processes
and facilities related to drug product manufacturing
Partner with Operations
and Automation functional areas on validation studies
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
Support operations and ensure compliance with regulatory
corporate and site requirements
How You'll Work.
Team & Collaboration
Partner with Operations, Quality, and Automation functional areas; Work on small cross functional teams
Communication Scope
Ability to summarize and present project information clearly to management; transparent communication between departments; Communicates with Clarity
Process & Methodology
Project Management support, Project Management experience, manage multiple complex priorities simultaneously under tight timelines, create and maintain Gantt charts, dashboards, and tracking templates
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