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), and software development subject matter expertise, the Senior LIMS System Engineer at Cook MyoSite, Inc. is responsible, with limited management oversight, for the architectural design, software development, integration, and data integrity of LabWare LIMS and LabWare LIMS related application systems.
• Define technology solutions based on user/client needs, cost, data integrity needs, and required integration.
• Recognized SME for LabWare Laboratory Information Systems (LIMS), instrumentation systems, and/or environmental systems,
• Author application functional specifications and Design and integration documents.
• Drive the delivery of features for LabWare LIMS, instrumentation systems, and/or LabWare LIMS related application systems by configuration of parameters and workflows to define COTS application behavior or Programming (i.e. LIMS Basic, SQL, Python, etc.) to extend the capabilities of a COTS application
• Lead application demonstrations to ensure that end-user requirements are met.
• Develop software unit tests as part of commissioning LabWare LIMS and/or LabWare LIMS related applications.
• Create and review Standard Operating Procedures (SOPs) and training materials.
• Practice and stay current with ISPE GAMP best practices, FDA GxP regulations, and applicable ISO standards.
• Communicate cross-functionally, and with external parties including managing and coordinating activities with external consultants.
• Manage and/or monitor progress for large technical projects related to LabWare LIMS and LabWare LIMS related application systems by tracking activities; resolving problems; publishing progress reports; recommending actions.
• Provide guidance, coaching, training, review and/or delegate work to lower-level technical professionals as needed or required.
• Undergraduate degree in Engineering or Life Sciences or 7 years direct, relevant experience in LabWare LIMS Administration to provide a comparable background. Master’s degree in Computer Science, Information Systems, or Engineering is preferred
• Current LabWare LIMS Certifications: LIMS Administration 1, LIMS Administration 2, LabWare Configuration Using LIMS Basic
• Preferred current advanced LabWare LIMS Certifications: Visual Workflows, Reporting, SQC Charting, Instrument Integration using LabStation, Understanding Database and SQL Queries
• Minimum of 6+ years' experience in LabWare LIMS Administration
• 7+ years of software application experience in LabWare LIMS including ELN worksheets, Visual Workflows, and programming (i.e., LIMS Basic, SQL, Python.).
• 7+ years of experience in a Biotech/Pharmaceutical/Med Product manufacturing industry regulated by the FDA
• Advanced understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing
• Proficient knowledge of Microsoft Office software, and other general office equipment.
• 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.