IT Automation Project Specialist
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Role details
Tech stack
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Job description
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.
Requirements
- 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
About the company
PE Global is currently recruiting for an IT Automation Project Execution Specialist to join a leading global pharmaceutical organisation, supporting critical IT/OT automation and infrastructure projects.
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