Description

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.
• LabWare Admin I certification.

Key Skills

Education

Bachelor's Degree