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Katalyst CRO

Katalyst CRO is hiring: IT Manufacturing Support in Piscataway

Katalyst CRO, Piscataway, NJ, US, 08854

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Information Technology Specialist Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams. Demonstrated experience in tracking changes, coordinating document reviews and maintaining GxP‑compliant SOPs and providing end‑user training for regulated IT systems. Perform regular system health checks, monitor logs, and escalate issues to infrastructure or vendor support teams as needed. Support systems connectivity and software installation and maintenance for IT equipment. Strong understanding of CSV, 21 CFR Part 11, Data Integrity, Good Manufacturing Practices (cGMP) guidelines, Good Documentation Practices (cGDP), and other regulatory requirements. – Advanced Demonstrated hands‑on experience with LIMS Empower CDS, SCADA, PLCs, Waters, Agilent Caliber, and other industrial systems. – Advanced Experience with Computer System Validation (CVS) and Change Control processes. – Advanced Familiarity with systems such as MES, SCADA, Track and Trace, PI Historian, and eLogbook. – Intermediate Experience in managing data integrity and audit trail reviews. – Intermediate Education & Experience 5 years or more supporting IT systems in a lab/manufacturing or regulated environment (preferably pharmaceutical or biotech). 3 years or more supporting GxP‑regulated lab and/or manufacturing IT systems. Seniority level Mid‑Senior level Employment type Contract Job function Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr