IT Labs System Specialist

This position will provide support for the IT Laboratory applications that enable the BeOne Hopewell US Site Quality functions. This individual will partner with SMEs to provide solutions that support day to day business operations and deliver strong customer service.

This role will work independently with some supervision and provide technical direction, and support in the areas of Quality Control laboratory systems and some manufacturing systems.

This is an onsite role based in the Hopewell Site, NJ.

This individual will have some 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:

• Administer and maintain IT systems related to GMP, including laboratory information management systems (LIMS), manufacturing execution systems (MES), and enterprise resource planning (ERP) systems.

• Maintain system documentation, including change control records, system configurations, and user manuals, in accordance with regulatory requirements.

• Provide support for various lab instrument applications.

• Provide technical support and training to users on GMP IT systems, facilitating user adoption and system optimization.

• Some hands-on experience or familiarity with Laboratory information management systems (LIMS), Waters Empower CDS, Mettler Toledo LabX, SoftMax Pro, Environmental Monitoring 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.

• Troubleshoot and resolve technical issues, working with vendors as needed to ensure minimal disruption to operations.

• Bachelor's degree in information technology, Computer Science, STEM or related degree.

Qualifications:

• Bachelor's degree with a scientific / engineering / Information technology background.

• Minimum 2 years of relevant work experience in building, configuring, and supporting Quality Control systems.

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

• Previous experience in a GMP manufacturing or operations environment.

• Some experience or familiarity with at least one of the following platforms: Waters Empower CDS, SoftMax Pro, MT LabX, Thermo Fisher LIMS, Environmental Monitoring.

• Strong communication and customer service delivery skills.