LIMS System Engineer III
1 month ago
Cook Myosite, Inc., a leading player in the regenerative medicine industry, is seeking a highly skilled LIMS System Engineer III to join its team. As a key member of our IT department, you will be responsible for the technical lifecycle and day-to-day up-time of our Myosite LIMS applications.
Responsibilities- Manage the system lifecycle, including feature delivery, integration, modification, and maintenance of LabWare LIMS.
- Collaborate with process owners and the Labware LIMS departmental system owner to ensure their day-to-day and long-term LIMS system operational and project-related expectations are met.
- Function as an application-level or system-level administrator for LabWare LIMS as needed.
- Develop and maintain Standard Operating Procedures (SOPs) and documentation requirements.
- Support the delivery of LabWare LIMS features and workflows by configuring parameters and templates to define COTS application behavior.
- Develop reports and perform 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.
- Provide 2nd-level support for LabWare LIMS for manufacturing and laboratory operations as needed.
- Undergraduate degree in Engineering, Computer Science, Life Sciences, or 10+ years direct, relevant experience in LIMS Administration and Configuration.
- Minimum of 5+ years' experience in LabWare LIMS administration, including ELN integration, and application configuration.
- Minimum of 5+ years' experience in a LIMS-related role providing value for manufacturing or laboratory operations in Biotech, Pharmaceutical, or Medical Device manufacturing regulated by the FDA and subject to 21 CFR Part 11 requirements.
- Minimum of 2+ years' experience in LabWare LIMS with both SQL and LIMS Basic.
- Demonstratable ability to work in collaborative and independent work situations and environments while multitasking.
- Demonstratable effective verbal, written, and interpersonal skills.
- Demonstratable ability to prioritize and operate proactively with minimal need for supervision.
- Ability to travel on-site in Pittsburgh, PA.
Pittsburgh, PA - Relocation assistance available
Office SettingGeneral office, warehouse, and laboratory setting.
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