Automation Engineer
Posted 3 days ago by PE Global
£49 Per hour
Undetermined
Undetermined
Milton Keynes, England, United Kingdom
Summary: The Automation Engineer role at PE Global involves managing manufacturing automation projects for a pharmaceutical client in Milton Keynes. The position requires expertise in IT and OT systems within regulated environments and includes responsibilities across the project lifecycle. The initial contract is for six months, focusing on compliance with GxP regulations and collaboration with various teams. Candidates must have significant experience in automation and project management within the pharmaceutical sector.
Key Responsibilities:
- Manage manufacturing automation projects to ensure delivery against business requirements
- Support all phases of the project lifecycle including requirements gathering, design, testing, installation, qualification, implementation, and training
- Design, develop, and maintain automation solutions for IT and OT systems within a regulated manufacturing environment
- Support the delivery of automation and infrastructure projects, including system upgrades and migrations
- Administer and support Windows Server 2022 environments and associated infrastructure
- Ensure systems remain compliant with GxP regulations through validation, documentation, and lifecycle management activities
- Create and maintain validation documentation including IQ/OQ/PQ protocols, SOPs, risk assessments, and validation plans
- Support the Software Development Lifecycle (SDLC) within a validated pharmaceutical environment
- Configure and troubleshoot network infrastructure including VLANs, TCP/IP, routing, switching, and firewalls
- Support and integrate manufacturing and laboratory systems including Rockwell FactoryTalk, Mettler Toledo FormWeigh, and Environmental Monitoring Systems (EMS)
- Collaborate with Quality, Manufacturing, Engineering, and IT teams to ensure system integrity and compliance
- Work closely with Project Managers and stakeholders to deliver automation projects in line with agreed timelines and objectives
- Provide technical leadership and subject matter expertise across automation projects
Key Skills:
- 5 years' experience delivering manufacturing automation, IT/OT, or infrastructure projects within regulated environments
- Degree in IT, Automation, Engineering, or a related discipline, or equivalent industry experience
- Previous experience working within pharmaceutical manufacturing is essential
- Demonstrated application of ISA-88 (S88) and ISA-95 (S95) standards within manufacturing automation environments
- Strong understanding of automation scope principles and manufacturing IT architecture standards
- Experience managing projects through the full lifecycle from concept and design through qualification and operational handover
- Strong experience administering Windows Server 2022 or later environments
- Experience working within GxP-regulated environments, including validation and compliance activities
- Knowledge of Data Integrity requirements including 21 CFR Part 11 and Annex 11 principles
- Hands-on experience with system validation, lifecycle management, and GxP documentation
- Strong understanding of SDLC processes in regulated industries
- Experience supporting or integrating Rockwell FactoryTalk, Mettler Toledo FormWeigh, and Environmental Monitoring Systems (EMS)
- Solid networking knowledge including VLANs, TCP/IP, switching, and routing fundamentals
- Experience with scripting and automation tools such as PowerShell
- Familiarity with VMware virtualisation technologies
- Understanding of OT cybersecurity principles and best practices
- Experience working with SCADA systems is advantageous
Salary (Rate): £48.95 hourly
City: Milton Keynes
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: IT
Detailed Description From Employer:
PE Global is currently recruiting for an experienced Automation Engineer to join our pharmaceutical client based in Milton Keynes. The role is an initial 6-month contract and the rate for this role is £48.95 p/hr PAYE.
Key Responsibilities:
- Manage manufacturing automation projects to ensure delivery against business requirements
- Support all phases of the project lifecycle including requirements gathering, design, testing, installation, qualification, implementation, and training
- Design, develop, and maintain automation solutions for IT and OT systems within a regulated manufacturing environment
- Support the delivery of automation and infrastructure projects, including system upgrades and migrations
- Administer and support Windows Server 2022 environments and associated infrastructure
- Ensure systems remain compliant with GxP regulations through validation, documentation, and lifecycle management activities
- Create and maintain validation documentation including IQ/OQ/PQ protocols, SOPs, risk assessments, and validation plans
- Support the Software Development Lifecycle (SDLC) within a validated pharmaceutical environment
- Configure and troubleshoot network infrastructure including VLANs, TCP/IP, routing, switching, and firewalls
- Support and integrate manufacturing and laboratory systems including Rockwell FactoryTalk, Mettler Toledo FormWeigh, and Environmental Monitoring Systems (EMS)
- Collaborate with Quality, Manufacturing, Engineering, and IT teams to ensure system integrity and compliance
- Work closely with Project Managers and stakeholders to deliver automation projects in line with agreed timelines and objectives
- Provide technical leadership and subject matter expertise across automation projects
Requirements:
- 5 years' experience delivering manufacturing automation, IT/OT, or infrastructure projects within regulated environments
- Degree in IT, Automation, Engineering, or a related discipline, or equivalent industry experience
- Previous experience working within pharmaceutical manufacturing is essential
- Demonstrated application of ISA-88 (S88) and ISA-95 (S95) standards within manufacturing automation environments
- Strong understanding of automation scope principles and manufacturing IT architecture standards
- Experience managing projects through the full lifecycle from concept and design through qualification and operational handover
- Strong experience administering Windows Server 2022 or later environments
- Experience working within GxP-regulated environments, including validation and compliance activities
- Knowledge of Data Integrity requirements including 21 CFR Part 11 and Annex 11 principles
- Hands-on experience with system validation, lifecycle management, and GxP documentation
- Strong understanding of SDLC processes in regulated industries
- Experience supporting or integrating Rockwell FactoryTalk, Mettler Toledo FormWeigh, and Environmental Monitoring Systems (EMS)
- Solid networking knowledge including VLANs, TCP/IP, switching, and routing fundamentals
- Experience with scripting and automation tools such as PowerShell
- Familiarity with VMware virtualisation technologies
- Understanding of OT cybersecurity principles and best practices
- Experience working with SCADA systems is advantageous
Please note PE Global cannot provide visa sponsorship for this role, candidates will need the full right to live and work within the UK for at least the next 6 months.