Amneal Pharmaceuticals
IT Manufacturing Support Associate
Amneal Pharmaceuticals, Piscataway, New Jersey, United States
Amneal Pharmaceuticals is seeking an IT Systems Support Associate to provide critical support for both laboratory and manufacturing IT systems. The role ensures the stability, compliance, and performance of GxP‑regulated systems in Quality Control (QC), Analytical R&D, and manufacturing environments.
Description
This cross‑functional role serves 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 maintains system integrity, manages change controls, and aligns with regulatory requirements including 21 CFR Part 11 and ALCOA+ data integrity standards. Essential Functions
Provide technical support for laboratory 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 drafting, reviewing, maintaining, and adhering to GxP‑compliant SOPs and system documentation. Support audit preparation and provide assistance during regulatory inspections. Deliver end‑user training for regulated IT systems. Additional Responsibilities
Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams. Demonstrate experience in tracking changes, coordinating document reviews, and maintaining GxP‑compliant SOPs while 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. Education
Bachelor’s Degree (BA/BS) in Computer Science or Engineering – Required Experience
5+ years supporting IT systems in a lab, manufacturing, or regulated environment (preferably pharmaceutical or biotech). 3+ years supporting GxP‑regulated lab and/or manufacturing IT systems. Skills
Strong understanding of CSV, 21 CFR Part 11, Data Integrity, Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), and other regulatory requirements – Advanced. Hands‑on experience with LIMS, Empower CDS, SCADA, PLCs, Waters, Agilent Caliper, and other industrial systems – Advanced. Experience with Computer System Validation (CSV) and Change Control processes – Advanced. Familiarity with MES, SCADA, Track and Trace, PI Historian, and eLogbook – Intermediate. Experience 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. Licenses
GAMP 5 or 21 CFR Part 11 training – Upon Hire – Required. A+ CompTIA and/or N+ CompTIA Technical Certifications – Preferred. ITIL or similar certification – Preferred. Compensation and Benefits
The base salary for this position ranges from $32.00 to $38.00 per hour. Amneal offers short‑term incentive opportunities, such as a bonus or performance‑based award, within the first 12 months. The company’s total rewards program includes competitive health and insurance benefits, a 401(k) matching contribution, and employee well‑being programs.
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This cross‑functional role serves 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 maintains system integrity, manages change controls, and aligns with regulatory requirements including 21 CFR Part 11 and ALCOA+ data integrity standards. Essential Functions
Provide technical support for laboratory 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 drafting, reviewing, maintaining, and adhering to GxP‑compliant SOPs and system documentation. Support audit preparation and provide assistance during regulatory inspections. Deliver end‑user training for regulated IT systems. Additional Responsibilities
Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams. Demonstrate experience in tracking changes, coordinating document reviews, and maintaining GxP‑compliant SOPs while 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. Education
Bachelor’s Degree (BA/BS) in Computer Science or Engineering – Required Experience
5+ years supporting IT systems in a lab, manufacturing, or regulated environment (preferably pharmaceutical or biotech). 3+ years supporting GxP‑regulated lab and/or manufacturing IT systems. Skills
Strong understanding of CSV, 21 CFR Part 11, Data Integrity, Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP), and other regulatory requirements – Advanced. Hands‑on experience with LIMS, Empower CDS, SCADA, PLCs, Waters, Agilent Caliper, and other industrial systems – Advanced. Experience with Computer System Validation (CSV) and Change Control processes – Advanced. Familiarity with MES, SCADA, Track and Trace, PI Historian, and eLogbook – Intermediate. Experience 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. Licenses
GAMP 5 or 21 CFR Part 11 training – Upon Hire – Required. A+ CompTIA and/or N+ CompTIA Technical Certifications – Preferred. ITIL or similar certification – Preferred. Compensation and Benefits
The base salary for this position ranges from $32.00 to $38.00 per hour. Amneal offers short‑term incentive opportunities, such as a bonus or performance‑based award, within the first 12 months. The company’s total rewards program includes competitive health and insurance benefits, a 401(k) matching contribution, and employee well‑being programs.
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