Engineering - Lab System Engineer

50% onsite

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 routing 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. This requires partnering with all levels of laboratory personnel, Information Technology, analytical support teams, and Quality Assurance to ensure processes are designed and maintained for lab systems to meet business and agency requirements with operational efficiency in mind.

Major Duties and Responsibilities

• Create and maintain 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.

• 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

• 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.

• Contribute tothe development/maintenance of processes for effective communication/visual dashboards for lab system work in progress and tracking team metrics.

• Assist with compiling/tracking team metrics.

• Author, revise, and/or review procedural documents, such as SOPs and WIs and contribute to the development of associated training content.

• Train users and less experienced staff on use of lab systems.

• Provide ad hoc support to users for issues/questions on the lab system.

• Communicate technical issues and activity status updates to team members/direct management.

• Process user account requests for system access.

• Maintain up to date knowledge on lab system functionality and apply functionality to improve system use and ensure efficient user experience within the systems.

• Participate on/Lead teams in support of business process improvements/operational excellence.

• Assist with management of the day to day activities and prioritization of work, as business needs require.

• Present information at group/department meetings.

• Provide support for internal compliance and regulatory agency inspections as required.

Required Knowledge/Skills/Qualifications

Education:

Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 2 to 4 years' experience.
Experience/Knowledge:
• 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…