IT Manufacturing Support
Katalyst HealthCares & Life Sciences
Job Title
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.
Roles And Responsibilities
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 And Experience
5 years or more in Experience supporting IT systems in a lab/manufacturing or regulated environment (preferably pharmaceutical or biotech
3 years or more in Experience supporting GxP-regulated lab and/or manufacturing IT systems.
Vacancy posted 1 day ago
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