Amneal Pharmaceuticals is hiring: IT Manufacturing Support Associate in Piscataw

Overview

Amneal Pharmaceuticals is seeking an IT Systems Support Associate to 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 maintain system integrity, manage change controls, and ensure alignment with regulatory requirements including 21 CFR Part 11 and ALCOA+ data integrity standards.

Responsibilities

• Provide technical support for lab and manufacturing systems (e.g., LIMS, Empower, SCADA, e-Logbooks, PLC interfaces), and 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 drafting, reviewing, maintaining, and adhering to GxP-compliant SOPs and system documentation; assist in audit preparation and 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 (CSV) activities, such as drafting URS, IQ/OQ/PQ documentation and validation protocols; maintain and manage SOPs related to IT systems and provide user training as needed; collaborate 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 uptime and ensure system availability for business applications.

Additional Responsibilities

• Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams.
• Track changes, coordinate document reviews, maintain GxP-compliant SOPs, and provide 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.

Qualifications

• Education: Bachelor's Degree (BA/BS) Computer Science or Engineering - Required
• Experience: 5+ years supporting IT systems in a lab/manufacturing or regulated environment (pharma/biotech preferred); 3+ years supporting GxP-regulated lab and/or manufacturing IT systems.
• Skills:
  • Strong understanding of CSV, 21 CFR Part 11, Data Integrity, cGMP and cGDP guidelines, and related regulatory requirements.
  • Hands-on experience with LIMS, Empower CDS, SCADA, PLCs, Waters, Agilent Caliber, and other industrial systems.
  • Experience with Computer System Validation (CSV) and Change Control processes.
  • Familiarity with MES, SCADA, Track and Trace, PI Historian, and eLogbook.
  • Experience in managing data integrity and audit trail reviews.
• Specialized Knowledge: GMP 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
• Licenses: GAMP 5 or 21 CFR Part 11 training—Upon Hire (Required); A+ CompTIA and/or N+ CompTIA certifications (Preferred); ITIL or similar certification (Preferred)

Compensation & Benefits

The base salary for this position ranges from $32.00 to $38.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal believes these ranges reflect its good-faith estimate of pay at posting time. Individual compensation will be determined based on qualifications, experience, geographic location and other relevant skills. Our Total Rewards program includes a comprehensive benefits plan, health and insurance coverage, and a significant 401(k) matching contribution to support retirement. We also promote employee well-being with programs that help you balance career and life commitments.