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CSV & DI Compliance Manager

Scientific Protein Laboratories • Waunakee, WI, US • published 2026-10-08 09:03:35.789962

Description

JOB SUMMARY Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a CSV \& DI Compliance Manager. In this role you will establish, govern, and sustain the computerized system validation (CSV) and data integrity (DI) program for all GxP computerized systems at the SPL Waunakee site, across IT business and laboratory systems and OT process systems. You will set the site’s CSV and DI standards, procedures, and policies across Quality, IT, and Engineering, and direct the IT and OT teams that implement them ensuring that every GxP system is validated, compliant, and defensible under regulatory inspection. This role will manage the CSV Engineer, provide functional direction to the automation engineers performing hands\-on OT work, and partner with QA Validation, which retains in...

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