Senior Pharma OT Executive - GxP & CSV Leader

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

Job summary

United Consulting Hub, Inc. seeks a Senior OT Executive to lead OT systems, automation, CSV and GxP compliance in a pharmaceutical manufacturing setting in New Jersey.

This role demands deep domain knowledge across SCADA, DCS, PLCs, HMI, MES, and GMP processes, with a focus on regulatory alignment and lifecycle validation. You will partner with QA, IT, and operations to ensure robust change control, audits, and risk assessments, while delivering documentation, qualification activities, and

Qualifications

• 5–10+ years of OT, Automation, CSV, or GxP IT/OT experience.
• Pharmaceutical, biotech, medical device, or regulated industry experience.
• Knowledge of SCADA, DCS, PLC, HMI, MES, BMS, EMS, Historian, and LIMS.
• Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and ALCOA+.
• CSV experience including IQ/OQ/PQ, risk assessments, RTM, validation plans, and reports.
• Windows Server, Active Directory, VMware/Hyper-V, SQL/Oracle.
• OT networking, VLANs, firewalls, switches, backup/recovery, and cybersecurity.
• Experience with change control, incident management, preventive maintenance, FAT/SAT, commissioning, and qualification.
• Audit/inspection support and strong technical documentation skills.
• Excellent troubleshooting, vendor coordination, and stakeholder-management skills.
• Preferred: GAMP 5/CSV, ITIL, OT Cybersecurity, CISA/CISSP certifications

Responsibilities

• Support OT systems, automation, GxP, CSV, infrastructure, and compliance in a pharmaceutical manufacturing environment.
• Manage OT networking, cybersecurity, and IT/OT integration.
• Coordinate audits/inspections and prepare technical documentation.
• Lead change control, incident management, preventive maintenance, FAT/SAT, commissioning, and qualification activities.

Skills

OT

Automation

CSV

GxP IT/OT

Regulatory Compliance

GAMP 5

21 CFR Part 11

EU Annex 11

ALCOA+

SCADA

DCS

PLC

HMI

MES

BMS

EMS

Historian

LIMS

IQ/OQ

PQ

Risk Assessments

Validation Plans

Docs/Documentation

Windows Server

VMware/Hyper-V

SQL/Oracle

Cybersecurity basics

Change Control

Audit/Inspection

Tools

SCADA

DCS

PLC

HMI

MES

BMS

EMS

Historian

LIMS

GxP IT/OT toolsets

Job description

United Consulting Hub, Inc. seeks a Senior OT Executive to lead OT systems, automation, CSV and GxP compliance in a pharmaceutical manufacturing setting in New Jersey.

This role demands deep domain knowledge across SCADA, DCS, PLCs, HMI, MES, and GMP processes, with a focus on regulatory alignment and lifecycle validation. You will partner with QA, IT, and operations to ensure robust change control, audits, and risk assessments, while delivering documentation, qualification activities, and