Pharma IT/OT Automation Engineer (GxP/Validation)

PE Global International

Milton Keynes

On-site

GBP 4,345,000 - 7,389,000

Full time

3 days ago

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Job summary

PE Global International is recruiting for an IT Automation Project Execution Specialist to support critical IT/OT automation and infrastructure projects in a GMP environment. Location: Milton Keynes. Duration: 6 months. Start ASAP. Full-time, Monday–Friday.

The role focuses on delivering, upgrading and lifecycle managing validated systems, interfacing IT and OT, with hands-on work on Rockwell FactoryTalk, EMS, and SCADA. Visa sponsorship is not available.

Qualifications

5+ years delivering IT/OT, automation or infrastructure projects within regulated environments.
Experience in pharmaceutical manufacturing is essential.
Strong experience administering Windows Server 2022 or later.
Solid networking knowledge: VLANs, TCP/IP, switching, routing.
GxP documentation and system validation experience.
Knowledge of Data Integrity, 21 CFR Part 11 and Annex 1.
Experience with Rockwell FactoryTalk/SCADA/EMS is a plus.

Responsibilities

Design, develop and maintain automation solutions across IT and OT environments.
Administer and support Windows Server 2022 or later environments.
Support and integrate automated systems used within pharmaceutical manufacturing.
Ensure systems comply with GxP requirements, including validation and documentation standards.
Create and maintain GxP documentation (IQ/OQ/PQ, SOPs, risk assessments, validation plans).
Support the SDLC within a validated environment.
Configure and troubleshoot network infrastructure (VLANs, TCP/IP, routing, switching, firewalls).
Work with Quality, Manufacturing and Engineering to maintain system integrity and compliance.
Collaborate with Project Manager to deliver upgrades and projects.