IT/OT Automation Engineer - Pharma Compliance & SDLC

THE ROOM; Northampton; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

25 days holiday pro rata

Job summary

Confidential Pharma Client in Milton Keynes seeks an IT/OT Automation Engineer to support critical automation projects in a regulated pharmaceutical manufacturing environment.

You will implement and upgrade validated systems, support the full SDLC, and ensure GxP compliance with IQ/OQ/PQ, SOPs, risk assessments and validation plans. Collaboration with Quality, Manufacturing and Engineering is essential.

Qualifications

• Experience upgrading/migrating IT/OT systems in regulated environments.
• Stakeholder management in regulated environments.
• Pharma/biotech manufacturing exposure is a plus.

Responsibilities

• Design, develop, and maintain IT/OT automation solutions.
• Administer Windows Server environments (2022+).
• Support and integrate automated systems used in pharma manufacturing.
• Ensure systems comply with GxP with validation and documentation.
• Create/maintain IQ/OQ/PQ, SOPs, risk assessments, validation plans.
• Participate in SDLC within a validated environment.
• Configure/troubleshoot network infrastructure (VLANs, TCP/IP, switches, routers, firewalls).
• Support Rockwell FactoryTalk, Mettler Toledo FormWeigh, EMS.
• Collaborate with Quality, Manufacturing, and Engineering teams.
• Work with Project Manager to deliver upgrades and progress blockers.

Skills

Windows Server administration

GxP compliance

Networking fundamentals

PowerShell scripting

Rockwell FactoryTalk

Mettler Toledo FormWeigh

Environmental Monitoring Systems (EMS)

OT cybersecurity basics

SCADA systems

VMware virtualization

Education

Degree in IT, Automation, or related field (or equivalent experience)

Tools

Rockwell FactoryTalk

Mettler Toledo FormWeigh

VMware

PowerShell

Job description

Confidential Pharma Client in Milton Keynes seeks an IT/OT Automation Engineer to support critical automation projects in a regulated pharmaceutical manufacturing environment.

You will implement and upgrade validated systems, support the full SDLC, and ensure GxP compliance with IQ/OQ/PQ, SOPs, risk assessments and validation plans. Collaboration with Quality, Manufacturing and Engineering is essential.