Define, develop, deliver, and support GMP e-systems, with a primary focus on the LabWare LIMS at the manufacturing plant.
Responsibilities
Lead all phases of application and system integration, owning deliverables including User Requirements Specifications, Functional Specifications, Design Specifications, and test cases.
Drive collaboration between Quality, Manufacturing, Supply Chain, Facilities, and Tech Transfer to develop business justifications and document requirements.
Execute GMP validation activities, including the development and execution of IQ/OQ/PQ testing.
Perform application administration for the Laboratory Information Management System (LIMS) and provide technical production support.
Manage system integrations for hardware such as Total Particulates, Plate readers, and Cell Viability Counters.
Required Skills
5+ years of experience in IT or QC within life sciences (biopharmaceutical preferred) supporting plant-based GMP applications.
Proven administrative technical experience with LabWare LIMS.
Experience working within a GxP environment.
Experience performing system integrations involving laboratory equipment.
Proficiency developing SQL queries using T-SQL.
Bachelor's Degree in a technology or relevant scientific discipline.
Strong understanding of laboratory business processes and the software development lifecycle (SDLC).
Demonstrated ability in troubleshooting and critical thinking.
Preferred Skills
LabWare LIMS development experience.
Experience developing reports using Crystal Reports.