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LIMS System Engineer III

2 months ago

Pittsburgh, Pennsylvania, United States Cook Group Full time
Overview

Cook MyoSite, Inc., a part of the Cook Group, Inc. family of companies, is dedicated to making regenerative medicine a part of everyday medicine. Our core technology, autologous muscle-derived cells, is being investigated for the potential treatment of several muscle-related disorders.

We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours.

Responsibilities
  • Manage the technical lifecycle of MyoSite LIMS applications, ensuring day-to-day up-time and operational excellence.
  • Collaborate with process owners and the Labware LIMS departmental system owner to meet their expectations for LIMS system operational and project-related needs.
  • Function as an application level or system level administrator for LabWare LIMS as needed.
  • Develop and maintain Standard Operating Procedures (SOPs) and documentation requirements, including requirement specifications, functional specifications, configuration specifications, and testing documents.
  • Support the delivery of LabWare LIMS features and workflows by configuring parameters and templates to define COTS application behavior, developing reports, and programming (LIMS Basic & SQL) for smaller-scale enhancements and troubleshooting.
  • Execute formal testing and guide the validation team during validation planning and qualification activities for LabWare LIMS enhancements and upgrades.
  • Create and review SOPs and training materials, conduct training, and practice ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.
  • Communicate cross-functionally and with external consultants, and review and/or delegate work to technical professionals as needed.
  • Provide 2nd level of support for LabWare LIMS for manufacturing and laboratory operations as needed, including off-hours.
Qualifications
  • Undergraduate degree in Engineering, Computer Science, Life Sciences, or 10+ years direct, relevant experience in LIMS Administration and Configuration to provide a comparable background.

Cook MyoSite, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We offer a hybrid work model and relocation assistance for the right candidate.