IT Manufacturing Support Associate

Role Summary

IT Manufacturing Support Associate responsible for providing critical support for laboratory and manufacturing IT systems, ensuring stability, compliance, and performance of GxP-regulated systems in QC, Analytical R&D, and manufacturing environments. Serves as a liaison between IT and OT, supporting systems such as LIMS, Empower, Stability systems, SCADA, e-Logbooks, and PLC networks, and maintaining system integrity, change control, and regulatory alignment (21 CFR Part 11, ALCOA+).

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 R&D). 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 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

• Bachelors Degree (BA/BS) in Computer Science or Engineering - Required
• 5+ years experience supporting IT systems in a lab/manufacturing or regulated environment (preferably pharmaceutical or biotech)
• 3+ years experience supporting GxP-regulated lab and/or manufacturing IT systems

Skills

• Strong understanding of CSV, 21 CFR Part 11, Data Integrity, cGMP, cGDP, and regulatory requirements
• Hands-on experience with LIMS, Empower, CDS, SCADA, PLCs, Waters, Agilent Caliber, and other industrial systems
• Experience with CVS and Change Control processes
• Familiarity with MES, SCADA, Track and Trace, PI Historian, and eLogbook
• Experience managing data integrity and audit trail reviews

Education

• Details above in Qualifications

Additional Requirements

• GAMP 5 or 21 CFR Part 11 training on hire required
• CompTIA A+ and/or Network+ certifications preferred
• ITIL or similar certification is a plus