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Description

We are seeking an IT Systems Support Associate role that will provide critical support for both laboratory and manufacturing IT systems. This cross-functional role ensures the stability, compliance, and performance of GxP-regulated systems in Quality Control (QC), Analytical R& D, and manufacturing environments. The ideal candidate will serve as a key liaison between Information Technology (IT) and Operational Technology (OT), supporting systems such as LIMS, Empower (CDS), Stability systems, SCADA, e-Logbooks, and PLC networks. The coordinator will be instrumental in maintaining system integrity, managing change controls, and ensuring alignment with regulatory requirements including 21 CFR Part 11 and ALCOA+ data integrity standard

Essential Functions:

+ Provide technical support for lab and manufacturing systems (e.g., LIMS, Empower, SCADA, e-Logbooks, PLC interfaces, and other lab informatics platforms used in QC and AR& D labs).Ensure day-to-day operations including user access provisioning, issue resolution, and system monitoring. Act as a bridge between IT and OT teams to ensure seamless integration and functionality of industrial systems. Assists in the draft, review, maintenance, and adherence of GxP-compliant SOPs and system documentation. Assist in audit preparation and provide support during regulatory inspections. Deliver end-user training for regulated IT systems.

+ Participate in commissioning and qualification of IT systems and assist in Computer System Validation (CVS) activities, such as draft URS, IQ/OQ/PQ documentation and validation protocols, maintain and manage SOPs related to IT systems and provide user training as needed. Collaborate closely with vendors and internal teams to deploy upgrades, patches, and changes under Change Control procedures.

+ Ensure systems comply with 21 CFR Part 11, Annex 11, and data integrity standards (ALCOA+). Support periodic backup/restoration testing, disaster recovery, and change management of IT systems. Monitor up time and ensure system availability for business applications.

Requirements

Additional Responsibilities:

+ 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

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.

Skills:

+ 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

Specialized Knowledge:

+ GMP (Good Manufacturing Practice) standards and 21 CFR Part 11

+ Data integrity principles (ALCOA)

+ Familiarity with GMP systems, audit procedures, and IT quality documentation

+ Working knowledge of validated environments, or manufacturing software preferred

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