Description

Define, develop, deliver, and support GMP e-systems, primarily LabWare LIMS, at the manufacturing plant. This role owns the full lifecycle of application and system integration, from requirements to validation and production support.

Responsibilities

• Lead application and system integration phases, owning User Requirements Specifications, Functional Specifications, Design Specifications, and test cases.
• Drive collaboration between Quality, Manufacturing, Supply Chain, Facilities, and Tech Transfer to document requirements and develop business justifications.
• 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 laboratory 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 and technical experience with LabWare LIMS.
• Experience working within a GxP environment.
• Experience performing system integrations involving laboratory equipment.
• Proficiency in developing SQL queries using T-SQL.
• Strong understanding of laboratory business processes and the software development lifecycle (SDLC).
• Bachelor's Degree in a technology or relevant scientific discipline.

Preferred Skills

• LabWare LIMS development experience.
• Experience developing reports using Crystal Reports.
• LabWare Admin I certification.

Key Skills

Education

Bachelor's Degree