Job DescriptionDescription: 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 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.
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
Qualifications
Education: - Bachelors Degree (BA/BS) Computer Science or Engineering - Required
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
Licenses: - GAMP 5 or 21 CFR Part 11 training-Upon Hire-Required
- A+ CompTIA and/or N+ CompTIA Technical CertificationsPreferred
- ITIL or similar certification is a plus.Preferred
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 ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.