About the role

Milton Keynes, United KingdomOn-site

IT Automation Engineer

About

We are seeking a skilled and motivated IT Automation Engineer to join our team within a regulated pharmaceutical environment. This role is responsible for implementing automation and IT infrastructure projects, ensuring compliance with GxP standards and supporting validated systems across the SDLC lifecycle.

You will work at the intersection of IT and operational technology (OT), supporting critical manufacturing systems.

Responsibilities

• Design, develop, and maintain automation solutions for IT and OT systems
• Administer and support Windows Server environments (2022 or later)
• Support and integrate automated systems used in pharmaceutical manufacturing
• Ensure systems comply with GxP regulations, including validation and documentation
• Create and maintain GxP documentation (IQ/OQ/PQ, SOPs, risk assessments, validation plans)
• Participate in and support the Software Development Lifecycle (SDLC) in a validated environment
• Configure and troubleshoot network infrastructure, including understanding of VLANs, routing, switching, and firewalls
• Support industrial and lab systems including:
Rockwell FactoryTalk platforms
Mettler Toledo FormWeigh systems
Environmental Monitoring Systems (EMS)
• Collaborate with Quality, Manufacturing, and Engineering teams to ensure system integrity and compliance
• Work with the Project Manager to deliver key system upgrades:
executing to project plans
communicating progress and blockers to Project Manager and key stakeholders (IT and Business)

Requirements

Required Skills & Experience
• Strong experience with Windows Server (2022 or later) administration
• Solid networking knowledge, including:
• VLAN configuration
• TCP/IP
• Switching and routing fundamentals
• Experience working within a GxP-regulated environment (Pharma, Biotech, Life Sciences)
• Hands-on experience with:
• GxP documentation and compliance processes
• Data Integrity - 21 CFR Part 11 / Annex 1
• System validation and lifecycle management
• Good understanding of SDLC within regulated environments
• Experience supporting or integrating:
• Rockwell FactoryTalk
• Mettler Toledo FormWeigh
• Environmental Monitoring Systems (EMS)
• Experience with scripting or automation tools (e.g., PowerShell)
• Strong analytical and problem-solving skills
Desirable Skills
• Experience with infrastructure automation tools or scripting frameworks
• Knowledge of virtualisation platforms (VMware)
• Understanding of OT cybersecurity principles
• Experience working with SCADA and EMS systems

Start

Immediate2 weeks notice1 month notice

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