Location: Milton Keynes
Duration: 6 months
Start Date: ASAP
Working Pattern: Full time, Monday–Friday
Rate: £31.54 - £53.64 per hour PAYE
The Role
We are looking for an experienced IT/OT Automation Engineer with a strong background in pharmaceutical manufacturing and GxP-regulated environments.
You will support the delivery, upgrade and lifecycle management of validated automation and infrastructure systems, working at the interface between IT and Operational Technology (OT).
Key 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, including IQ/OQ/PQ, SOPs, risk assessments and validation plans.
• Support the Software Development Lifecycle (SDLC) within a validated environment.
• Configure and troubleshoot network infrastructure, including VLANs, TCP/IP, routing, switching and firewalls.
• Support industrial and laboratory systems, including:
• Rockwell FactoryTalk
• Mettler Toledo FormWeigh
• Environmental Monitoring Systems (EMS)
• SCADA systems
• Work closely with Quality, Manufacturing and Engineering teams to maintain system integrity and compliance.
• Work alongside the Project Manager to deliver system upgrades and execute project plans.
• Support system upgrades, migrations and lifecycle activities.
Skills & Experience Required
• 5+ years' experience delivering IT/OT, automation or infrastructure projects within regulated environments.
• Previous experience working within pharmaceutical manufacturing is essential.
• Strong experience administering Windows Server 2022 or later.
• Solid networking knowledge, including VLAN configuration, TCP/IP, switching and routing.
• Proven experience working within a GxP-regulated environment such as Pharma, Biotech or Life Sciences.
• Hands-on experience with GxP documentation, compliance and system validation.
• Knowledge of Data Integrity, 21 CFR Part 11 and Annex 1.
• Good understanding of SDLC within a regulated environment.
• Experience with Rockwell FactoryTalk, Mettler Toledo FormWeigh and/or Environmental Monitoring Systems (EMS).
• Experience with scripting or automation tools such as PowerShell.
• Experience with infrastructure automation tools or scripting frameworks.
• Knowledge of VMware/virtualisation platforms.
• Understanding of OT cybersecurity principles.
• Experience working with SCADA and EMS systems.
• Strong analytical, troubleshooting and problem-solving skills.
• Experience managing stakeholders and communicating effectively within regulated environments.
• A degree in IT, Automation or a related discipline, or equivalent practical experience.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***
Apply through PE Global today to be considered for this opportunity.
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Salary description
£31.54 - £53.64 per hour