Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, 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. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
Incorporating life sciences subject matter expertise (SME), the Laboratory Information Management System (LIMS) System Engineer III at Cook MyoSite, Inc. is responsible for the technical lifecycle and day-to-day up-time of MyoSite LIMS applications.
• Serve as a LabWare LIMS system platform owner; e.g., responsibility for managing the system lifecycle including feature delivery, integration, modification, and maintenance.
• Responsible for working 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.
• Adhere to Standard Operating Procedures (SOPs) and documentation requirements while authoring requirement specifications, functional specifications, configuration specifications, and various testing (i.e., plan, scenarios, cases) documents.
• Support the delivery of LabWare LIMS features and workflows by the configuration of parameters and templates to define COTS application behavior, along with developing reports, and some programming (LIMS Basic & SQL) for smaller-scale enhancements and troubleshooting.
• Adhere to Standard Operating Procedures (SOPs) and documentation requirements while executing formal testing.
• Guide and support the validation team during validation planning and qualification activities for LabWare LIMS enhancements and upgrades.
• Create and review Standard Operating Procedures (SOPs) and training materials; conduct training for SOPs.
• Practice and stays current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.
• Communicate cross-functionally and with external consultants.
• 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.
• Undergraduate degree in Engineering, Computer Science, Life Sciences, or 10+ years direct, relevant experience in LIMS Administration and Configuration to provide a comparable background.
• LabWare LIMS Certifications: LIMS Administration 1, LIMS Administration 2, and Reporting.
• Minimum of 5+ years' experience in LabWare LIMS administration (including ELN integration) along with application configuration.
• Minimum of 5+ years’ of experience in a LIMS related role providing value for manufacturing or laboratory operations in Biotech, Pharmaceutical, or Medical Device manufacturing that was 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 of supervision.
• Hybrid position - Must have the ability to travel on-site in Pittsburgh, PA.
• Office Setting: General office, warehouse and laboratory setting.
• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.