Automation Compliance Engineer

SimoTech; Cork; On-site; EUR 85,000 - 120,000; Full time

Job summary

SimoTech is seeking an Automation Compliance Engineer to join a state-of-the-art biotechnology facility in Cork. You will act as the automation SME for Siemens PLC systems, leading CAPAs and supporting change controls to ensure GMP and data integrity across site systems.

The role involves collaborating with Quality, Operations, Engineering and Maintenance teams to drive continuous improvement and audit readiness while safeguarding reliability and compliance in a fast-paced manufacturing

Qualifications

• Bachelor's or Master's degree in Engineering, Computer Science or related disciplines.
• Minimum 7 years’ experience working with Siemens PLC system, hardware, applications, and associated compliance.
• 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.

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, obsolescence programmes and preventative maintenance initiatives.

Skills

Siemens PLC

CAPA investigations

GMP compliance

Change controls

Root cause analysis

Data integrity

Quality systems

Education

Bachelors or Masters in Engineering/Computer Science

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.

Automation Compliance Engineer 1716

SimoTech requires 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, obsolescence programmes and preventative maintenance initiatives.

Requirements

• Bachelors or Masters degree in Engineering, Computer Science or related disciplines.
• Minimum 7 years’ experience working with Siemens PLC system, hardware, applications, and associated compliance.
• 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.