**General Description:** This position will provide support for the IT Laboratory applications that enable the BeiGene Hopewell US Site Quality functions. This individual will partner with SMEs to provide solutions that support day to day business operations and improve ways of working. This individual will support projects and systems across the site. This role will work independently with some supervision and provide technical direction, and support in the areas of Quality Control laboratory systems. **This is an onsite role based in the Hopewell Site, NJ.** This individual will have experience in GMP change control, CAPA and investigations to support day to day operations; experience in software troubleshooting and working knowledge of data integrity principles. **Essential Functions of the job:** + Strong communication and customer service delivery. + Build strong relationships with the end user community. + Author and support SOPs, WIs, and supporting validation documentation. + Support of various lab instrument applications. + Hands-on experience with Laboratory information management systems (LIMS), Waters Empower CDS (Chromatography Data System), Mettler Toledo LabX, SoftMax Pro, Environmental Monitoring systems, and Quality Management systems. + Support the configuration, administration, and operational maintenance activities for site quality systems. + Requires working in an industrial manufacturing environment including gowning. + Support operations and ensure compliance with regulatory, corporate and site requirements. + Support the triage of tickets to ensure lab operations is seamless. + Experience working with end users to build best practices into the supported areas. **Qualifications:** + Bachelor’s degree with a scientific / engineering / Information technology background. + Minimum 4 years of relevant work experience in building, configuring, and supporting Quality Control systems. + Experience with software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Previous experience in a GMP manufacturing or operations environment. + Experience with at least one of the following platforms: Waters Empower CDS, SoftMax Pro, MT LabX, Thermo Fisher LIMS, Environmental Monitoring. + Experience authoring standard operating procedures. + Experience in providing support for small to medium-sized projects and outside vendors. + 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.