IT Manufacturing Support Associate

Amneal Pharmaceuticals • Piscataway, NJ

123d

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.

What This Job Offers

• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees