Senior OT Automation Lead for Pharma, CSV/GxP Expert

United Consulting Hub; New Jersey; On-site; USD 150,000 - 190,000; Full time

Job summary

United Consulting Hub in New Jersey seeks a Senior Operational Technology (OT) Executive with extensive pharma manufacturing, OT systems, automation, CSV, GxP compliance, and IT/OT infrastructure experience to support critical manufacturing, labs and utilities while ensuring reliability and regulatory compliance.

The role covers managing SCADA/DCS/ PLC/HMI/Historian, validating CSV activities, and coordinating with QA, QC, Engineering, IT and vendors to prepare for FDA/MHRA/EMA audits and

Qualifications

• 8+ years of OT / Automation / CSV experience in Pharma or Life Sciences.
• SCADA / DCS / PLC / HMI / Historian systems experience.
• CSV and GxP compliance knowledge.
• GAMP 5 / 21 CFR Part 11 / EU Annex 11 / ALCOA+ familiarity.
• Active Directory / Windows Server experience.
• OT cybersecurity and data integrity awareness.
• Coordination with QA, QC, Engineering, IT and vendors.
• FDA/MHRA/EMA audits support with validation documentation.

Responsibilities

• Manage and support SCADA, DCS, PLC, HMI, Historian, MES, BMS, and EMS systems.
• Support GxP computerized systems used in manufacturing and labs.
• Execute and maintain CSV activities and validation documents.
• Prepare/review URS, Risk Assessments, IQ/OQ/PQ, RTM, and reports.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+.
• Manage user access, AD, roles, permissions, and audit trails.
• Support OT networks, servers, VMware, databases.
• Troubleshoot OT applications, automation systems, hardware and software.
• Support FAT, SAT, commissioning, qualification, upgrades and implementations.
• Manage incident, change control, preventive maintenance, backup and DR activities.
• Support OT cybersecurity and data integrity initiatives.
• Coordinate with QA, QC, Engineering, IT and external vendors.
• Support audits and regulatory inspections with validation documentation.
• Maintain SOPs, work instructions, network diagrams and inventories.

Skills

OT / Automation / CSV experience

Vendor & cross-functional leadership

Documentation & troubleshooting

Regulatory & audits support

Tools

SCADA / DCS / PLC / HMI / Historian

SQL Server / Oracle

Active Directory / Windows Server

VMware / Hyper-V

OT Networking (VLAN / Firewall / Switches)

Job description

United Consulting Hub in New Jersey seeks a Senior Operational Technology (OT) Executive with extensive pharma manufacturing, OT systems, automation, CSV, GxP compliance, and IT/OT infrastructure experience to support critical manufacturing, labs and utilities while ensuring reliability and regulatory compliance.

The role covers managing SCADA/DCS/ PLC/HMI/Historian, validating CSV activities, and coordinating with QA, QC, Engineering, IT and vendors to prepare for FDA/MHRA/EMA audits and