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LIMS Systems Engineer III

2 months ago

Pittsburgh, Pennsylvania, United States K A Hamilton Associates Full time
Job Summary

We are seeking a highly skilled LIMS Systems Engineer III to join our team at K A Hamilton Associates. As a key member of our technical team, you will be responsible for the technical lifecycle and day-to-day up-time of our MyoSite LIMS applications.

Key Responsibilities
  • Manage the system lifecycle, including feature delivery, integration, modification, and maintenance, as the LabWare LIMS system platform owner.
  • 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.
  • Adhere to Standard Operating Procedures (SOPs) and documentation requirements while authoring requirement specifications, functional specifications, configuration specifications, and various 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 and stay current with 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 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.
  • 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 for supervision.
Physical Requirements
  • 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.