R&D Lab Systems & IT Specialist

BioSpace; New Jersey; On-site; USD 96,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid parental leave

Paid time off

Flexible spending accounts

Job summary

Legend Biotech USA Inc. seeks an R&D Applications Specialist to support laboratory IT capabilities and R&D systems in Somerset, NJ. You will help operate and enhance LabVantage LIMS/ELN, BMRAM configurations, and instrument/software interfaces while maintaining compliance with GxP standards.

You’ll collaborate with lab, manufacturing and IT teams, handle user provisioning, and contribute to change control and documentation. A BS in biotech field with 3–5 years’ experience is expected.

Qualifications

• BS degree with 3-5 years experience in Biotech/Pharmaceutical industry.
• Understanding of GxP software administration and configuration.
• Installing, configuring and supporting systems and applications in lab environments.
• Experience with direct customer/user interaction, including training.
• Familiarity with ticketing systems (ServiceNow, Jira, or similar).
• Must know SDLC and CSV.

Responsibilities

• Administrating and maintaining Equipment/Asset Platform (Blue Mountain RAM), LIMS/ELN (Labvantage) and various other lab applications used in R&D.
• Configure/enhance BMRAM as per business requirements. Maintain and support the system and ensure that it is compliant.
• Configure/develop enhancements to LabVantage LIMS/ELN system as per business requirements. Create and maintain master data/static data in lab systems by executing the appropriate change management process to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.
• Aid in troubleshooting and assist in technical support of both instrument software installed on lab computers and connectivity between computer and instrument.
• User account provisioning on stand-alone and networked equipment and instruments.
• User account provisioning on scientific software (e.g., FlowJo, Zageno, SnapGene, Journal Subscriptions, etc.).
• Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the systems.
• Contribute to team success by assisting colleagues with assigned work activities and deliverables, ensuring timely and effective execution of team responsibilities.
• Test changes/enhancements through dry runs, system test and user acceptance test.
• Evaluate, recommend and implement processes to improve compliance and the efficiency of laboratory testing operations (i.e visibility to testing queues, testing metrics monitoring, etc) to support product release, new products, and key performance indicators/lean lab metrics.
• Execute and document appropriate change control and/or verify changes executed by team members are accurate.
• Author, revise, and/or review procedural documents, such as SOP sand WIs and contribute to the development of associated training content.
• Provide support for internal compliance and regulatory agency inspections as required.
• Respond to system issues and troubleshoot to identify root cause.
• Provide support and systems management of R&D applications and lab computing environment in accordance with IT Policies and Procedures.
• Coordinate the necessary risk assessment and qualification protocols to support the GxP applicability of systems
• Track, document, and update incidents and requests accurately in the IT Service Management (ITSM) system
• Assist in updating any knowledge base articles.
• Maintain a willingness to learn new skills, processes, and technologies, and participate in training activities as directed to support individual and team success.

Skills

Lab IT support

GxP software

SDLC knowledge

CSV knowledge

Customer training

Problem solving

Education

BS degree

Tools

LabVantage LIMS

Blue Mountain RAM

ITSM systems

ServiceNow/Jira

Job description

Legend Biotech USA Inc. seeks an R&D Applications Specialist to support laboratory IT capabilities and R&D systems in Somerset, NJ. You will help operate and enhance LabVantage LIMS/ELN, BMRAM configurations, and instrument/software interfaces while maintaining compliance with GxP standards.

You’ll collaborate with lab, manufacturing and IT teams, handle user provisioning, and contribute to change control and documentation. A BS in biotech field with 3–5 years’ experience is expected.