Automation Compliance Engineer 1716

Simotechnology; Cork; On-site; EUR 65,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Benefits

Educational support

Career progression

Job summary

SimoTech is recruiting an Automation Compliance Engineer to join a state-of-the-art biotechnology facility in Cork. This role blends hands-on technical problem-solving with strict quality and compliance activities.

The automation SME will own Siemens PLC systems, drive CAPAs, support change controls, and ensure GMP data integrity across manufacturing and utility systems. You will collaborate with Quality, Operations, Engineering and Maintenance to optimise reliability and compliance.

Qualifications

• Bachelor or Master in Engineering or related field.
• 3+ years with Siemens PLC systems and related hardware.
• Experience with GMP-regulated environments and automation compliance.

Responsibilities

• Act as the automation SME for PLC deviations, investigations, CAPAs and quality events.
• Troubleshoot and perform root cause analysis on Siemens PLC systems in manufacturing.
• Lead development and closure of CAPAs arising from automation investigations.
• Collaborate with Quality, Engineering, Operations and Maintenance to resolve automation compliance issues.
• Review and support change controls, risk assessments and technical documentation.
• Identify recurring system issues and drive continuous improvement for reliability and compliance.
• Support audit readiness activities and provide automation expertise as required.
• Ensure automation systems remain compliant with GMP and data integrity requirements.
• Support lifecycle management including system upgrades and maintenance.

Skills

Siemens PLC

CAPA management

GMP compliance

Root cause analysis

Change controls

Audit readiness

Cross-functional teamwork

Education

Bachelor's or Master's in Engineering/CS

Tools

Siemens PLC hardware

Job description

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.

Key Responsibilities

• 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.
  

Requirements

• 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.
  

What SimoTech Can Offer

• 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.