Job Description

Lab Systems Specialist

This position is responsible for providing technical support in the development and maintenance of various QC lab systems user workflows to support various site manufacturing, stability, method transfer and non-routine testing activities to ensure compliance with procedures, methods, specifications, sampling plans, and data reporting requirements for raw material, water, microbial, biologics drug substance and/or biologics drug product testing.

Key Responsibilities:

Method Execution and Instrument Integration:

• Create, maintain and review master data/static data in current/future lab systems by executing the appropriate change management process to ensure accuracy of the configured analytical workflow to support laboratory testing activities and to ensure business, project and/or investigation/CAPA timelines are met.

• Support review of change controls associated with lab systems, identify system impact, and develop appropriate change actions required to support implementation of the change, including impact to interfacing systems.

• Execute and document appropriate change control and/or verify changes executed by a team member are accurate associated within the lab system.

• Review method/specification changes and work with appropriate SMEs to assess impact to lab systems data set up

• Execute standardization plan and contribute to identifying opportunities to standardize,

• Test changes/enhancements through dry runs and receive feedback from lab users, when required.

• Setup verification testing as appropriate for the lab system.

• Execute User Acceptance Testing for system functionality changes.

• Communicate impact of lab system changes to integrated systems areas (i.e. trending system, MES, etc.).

• Collaborate/liase with appropriate laboratory, manufacturing, analytical support and/or site/global IT teams to ensure needs and requirements are accurate in the lab systems.

• 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.

Qualifications & Experience

• Minimum B.S. degree in a relevant scientific, computer or engineering program area with similar experiences

• Lab Data Systems experience is a must, ideally Method Builder experience.

• Advanced knowledge and in depth understanding of analytical techniques preferred.

• Proficient knowledge of a lab system such as Empower, LES, LIMS, MODA, CIMS, etc., understanding of system interfaces and impact of changes to each other.

• Proficient knowledge and understanding of Microsoft Office Applications (Access, Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.

• Ability to execute changes in the lab system independently, proactively identify problems, troubleshoot issues, and develop potential solutions.

• Respond to system issues and troubleshoot to identify cause.

• Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.

• Ability to exercise judgment and makes sound decisions within generally defined practices and policies to independently develop approach/solution. Consult with technical if needed.

For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)