IT Automation Project Execution Specialist

Our global pharmaceutical client based in Milton Keynes is seeking a skilled IT/OT Automation Engineer to support the delivery of critical automation and infrastructure projects within a regulated pharmaceutical manufacturing environment. The role focuses on implementing and upgrading validated systems, ensuring compliance with GxP standards, and supporting the full system lifecycle (SDLC). You will work at the interface between IT and Operational Technology (OT), supporting manufacturing systems that are critical to site operations.

• 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 and execute against project plans
• Communicate progress and blockers to Project Manager and key stakeholders (IT and Business)

• Experience working on system upgrades / migrations
• Stakeholder management in regulated environments
• 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
• 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

• 25 days holiday pro rata

- This is initially a 6-month PAYE contract with a possibility of an extension. - The above list of duties is not exhaustive and is subject to change. The post holder may be required to undertake other duties within the scope and grading of the post. - Qualifications & Education: - Degree in IT, Automation, or related field (or equivalent experience) - 5+ years' experience delivering IT/OT or automation projects within regulated environments, ideally within the pharmaceutical industry - Experience working in pharmaceutical manufacturing required