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BeOne Medicines Senior Engineer I, Site Automation in Pennington, New Jersey

General Description:

BeOne Medicines is seeking a highly motivated and organized Site Automation Engineer to join our team at the Hopewell, NJ site. The successful candidate will be responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation of validated computer systems for the shopfloor and process automation systems, in close collaboration with the Global Technology Solutions (GTS) team. The individual ensures reliable operation and implementation of all automation systems 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 Facility, Utility and Metrology, instrumentation /control services. Projects may often require independent decision making and exercising judgment. This role will be based in Hopewell NJ and report to the Senior Engineer II, Site Automation.

Responsibilities:

  • Primary role is development and enhancements of the current site FactoryTalk DCS and FactoryTalk Batch systems.

  • Development of DCS libraries for deployment across multiple Automation platforms.

  • Development of Batch recipes with input from Process Engineering and Manufacturing.

  • Support projects in the design, development, and qualification of automated processes, equipment, and systems; including managing the work of internal engineers and outside vendors

  • Support the design, development, and qualification of automated processes, equipment, and systems and identify opportunities to improve existing processes, equipment, systems, and infrastructure

  • Develop and review technical documentation

  • Support of various Control System hardware and software

  • Participate and lead in controls fault analysis and remediation

  • Support the configuration, administration and maintenance activities of the site manufacturing and automation systems, including process control systems, building automation systems, manufacturing execution systems, and data historian

  • Directly support operations with troubleshooting and issue resolution with respect to computer and automation systems

  • 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

  • Collaborate and work closely with Automation teams at other sites in China

  • 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

Required Skills/Experience:

  • BS or higher in engineering and/or related discipline.

  • Minimum 5 years of experience in biopharmaceutical manufacturing, engineering, and/or project management and at least 3 years of project management experience in biologics or GMP.

  • Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV)

  • Strong experience with the following platforms is required: Rockwell DCS, Allen Bradley PLC, Rockwell FTView, MS-SQL, Inductive Automation Ignition.

  • Experience with Siemens PLCs, WinCC, and OSI PI Historian is recommended.

  • Experience with instrumentation and control panel hardware as required by the job

  • Experience with computer systems validation practices (GAMP)

  • 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.

Preferred Skills/Experience

  • OE and/or LEAN Methodologies

Physical Requirements :

  • 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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