Hopewell, NJ, 08525, USA
7 days ago
GTS Site Operations Specialist
**General Description:** This position will provide support and maintain IT Systems in the BeiGene Hopewell US. The individual will be responsible for reliable operation and implementation of computer platforms and systems enabling the site.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 Quality, Manufacturing, Engineering & Warehouse. Projects may often require independent decision making and exercising of judgment. This is an onsite role based in the Hopewell Site, NJ. **Essential Functions of the job:** + Lead and support projects in the design, development, and qualification of site systems which may include managing the work of internal technical staff and outside vendors. + Perform on-site and remote analysis, diagnosis, and resolution of complex computer system issues for the enduser community and industrial systems. + Recommend and implement corrective solutions, solving incidents and ensure meeting SLA requirements. + Support all office and industrial applications and hardware, including laptops, iPads, and iPhones. + Build, configure, repair, and maintain new and existing computer systems and peripherals. + Develop and review technical documentation. + Ensure SDLC, testing, validation, training activities are followed and documented for system implementations. + Support the configuration, administration, deployment and operational maintenance activities for site systems. + Support operations and ensure compliance with regulatory, corporate and site requirements. + Collaborate and work closely with cross-functional teams within the site and at other sites. + 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. **Other Qualifications:** + Strong experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Previous experience in a GMP manufacturing or operations environment. + Strong experience with at least three or more of the following platforms: Windows, Networking, Quality Control systems, Process Control systems, Engineering systems, Collaboration tools, Audi Visual Equipment + Experience authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents. + Effective written and verbal communications skills. **Travel:** + Domestic and international travel less than 10 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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