Amneal Pharmaceuticals-posted 2 months ago
Piscataway, NJ
5,001-10,000 employees
Chemical Manufacturing

Amneal Pharmaceuticals is 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 standards.

  • 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.
  • Assist 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.
  • 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 with laboratory and manufacturing IT systems such as LIMS, Empower, SCADA, and e-Logbooks.
  • Knowledge of GxP regulations and compliance, specifically 21 CFR Part 11 and ALCOA+ standards.
  • Experience in drafting and maintaining GxP-compliant SOPs.
  • Ability to provide end-user training for regulated IT systems.
  • Experience in Computer System Validation (CVS) activities.
  • Strong problem-solving skills and ability to work collaboratively with IT and OT teams.
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