Overview
On Site
Full Time
Skills
Manufacturing Support
Patch Management
Antivirus
Microsoft Windows Server
Microsoft Operating Systems
Collaboration
IT Infrastructure
End-user Training
Software Installation
Good Manufacturing Practice
Documentation
LIMS
CaliberRM
Computerized System Validation
Change Control
MES
SCADA
Management
Data Integrity
Auditing
Pharmaceutics
GxP
Manufacturing
Job Details
Summary:
- 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
- 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.
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