Katalyst CRO
Katalyst CRO is hiring: IT Manufacturing Support in Piscataway
Katalyst CRO, Piscataway, NJ, US, 08854
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
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