Automation Compliance Engineer 1716

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

SimoTech require s an Automation Compliance Engineer to join our client at a state-of-the-art Biotechnology facility in Cork. This is a unique opportunity for an automation professional who enjoys combining hands-on technical problem-solving with quality and compliance activities.

The successful candidate will act as the automation subject matter expert for Siemens PLC systems, leading investigations into automation-related deviations, driving CAPAs, supporting change controls and ensuring systems remain compliant within a GMP-regulated manufacturing environment. This role offers the opportunity to influence site reliability, compliance and continuous improvement while working closely with Quality, Operations, Engineering and Maintenance teams.

• Act as the automation SME for PLC-related deviations, investigations, CAPAs and quality events.
  
• Troubleshoot and perform root cause analysis on issues associated with 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.
  
• Perform system compliance activities such as audit trail reviews and backup & restore resting.
  
• Support lifecycle management activities including system upgrades, obsolescenceprogrammesand preventative maintenance initiatives.
  

• Bachelors or Masters degree in Engineering, Computer Science or related disciplines.
  
• 3+ years' experience working with Siemens PLC systems and associated hardware and applications.
  
• 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.
  

• Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  
• Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  
• Opportunity to work with large corporate clients on exciting capital projects.