Automation Compliance Engineer

What is it like to work at SimoTech? With a strongcollaborative teamwork culture based on respect, trust and excellence, we playa critical partnering role to our clients' life-changing supply of products topatients. In return, there is excellent salary, benefits, career progression,educational support and much more.

Automation Compliance Engineer 1726

SimoTech requires an Automation Compliance Engineer to joinour client at a state-of-the-art Biotechnology facility in Limerick. This is aunique opportunity for a professional who enjoys combining hands-on technicalproblem-solving with quality and compliance activities.

The successful candidate will provide automation,compliance, and technical support to manufacturing process teams across thesite, with responsibility for systems including DeltaV and Siemens PLCplatforms. The role will involve leading investigations into automation-relateddeviations, driving CAPA implementation, supporting change control activities,and ensuring automation systems remain compliant within a GMP-regulatedenvironment.

Working closely with Quality, Operations, Engineering, andMaintenance teams, the successful candidate will play a key role in enhancingsystem reliability, maintaining regulatory compliance, and driving continuousimprovement initiatives that support safe and efficient manufacturingoperations.

Key Responsibilities

• Act as the automation representative for DeltaV and PLC-related deviations, investigations, CAPAs and quality events.
  
• Troubleshoot and perform root cause analysis on issues associated with DeltaV and Siemens PLC-controlled manufacturing and utility systems.
  
• Lead and support the development, implementation and closure of CAPAs arising from automation investigations.
  
• Collaborate with Quality, Engineering, Operations and Maintenance teams to resolve automation compliance issues.
  
• Review and support automation-related change controls, risk assessments and technical documentation.
  
• Identify recurring system issues and drive continuous improvement initiatives to enhance reliability and compliance.
  
• Support audit and inspection readiness activities, providing automation expertise as required.
  
• Ensure automation systems remain compliant with GMP, data integrity and site procedural requirements.
  
• Support lifecycle management activities including system upgrades, obsolescence programmes and preventative maintenance initiatives.
  
• Perform system compliance activities such as audit trail reviews and backup and restore testing.
  

Requirements

• Bachelors or Masters degree in Engineering, Computer Science or related disciplines.
  
• 2+ years' experience working with DeltaV and Siemens PLC systems and associated hardware and applications.
  
• 2+ years' experience investigating deviations, managing CAPAs and supporting change controls within a GMP-regulated environment.
  
• Strong troubleshooting and root cause analysis skills for automated manufacturing systems.
  
• Knowledge of GAMP software development lifecycle and ANSI/ISA-S88 industry standards.
  
• Strong problem-solving skills and the ability to work under pressure to meet deadlines.
  
• Excellent planning, organisation and communication skills required.
  
• Ability to work well with diverse, multi-disciplined teams.
  

What SimoTech CanOffer

• Roleprovides a high degree of autonomy to allow the successful candidate to reachtheir full potential.
  
• Developnew skills and enhance technical ability by working with innovativetechnologies in a multi-disciplined environment.
  
• Opportunityto work with large corporate clients on exciting capital projects.