IT Automation Project Execution Specialist

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

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.

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

Experience

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

Technical Skills

• 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

Benefits

• 25 days holiday pro rata

Contract

• 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

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