Process Automation Engineer

SimoTech; Limerick; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Autonomy

Skills development

Large corporate projects

Job summary

SimoTech is seeking a Process Automation Engineer to join a state-of-the-art Biotechnology facility in Limerick. This role combines hands-on technical problem-solving with quality and compliance activities within a GMP-regulated manufacturing environment, focusing on MES.

You will work with Manufacturing, Quality, Engineering and Maintenance to support MES, deviations, CAPAs and change controls, helping to sustain regulatory compliance and reliable operations across the site.

Qualifications

• Bachelor or Master degree in Engineering or related discipline.
• 2+ years’ experience with MES systems in GMP environments.
• Experience in deviations, CAPAs and change controls.
• Strong troubleshooting and root cause analysis skills.
• Knowledge of GAMP lifecycle and data integrity.
• Excellent planning and communication within cross-functional teams.

Responsibilities

• Act as MES representative for deviations, investigations, CAPAs and quality events.
• Lead development, implementation and closure of CAPAs from MES investigations.
• Collaborate with Quality, Engineering, Operations and Maintenance to resolve automation issues.
• Review MES change controls, risk assessments, and technical docs.
• Identify recurring system issues and drive continuous improvement.
• Support audit readiness with automation expertise.
• Ensure MES compliance with GMP and data integrity.
• Support lifecycle management including upgrades and maintenance.

Skills

MES systems

Deviation investigations

CAPA management

Change controls

GAMP lifecycle

Root cause analysis

GMP compliance

Cross-functional collaboration

Education

Bachelor's or Master's in Engineering or related

Tools

MES

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.

Process Automation Engineer 1726

SimoTech is seeking an Process Automation Engineer to join our client at a state-of-the‑art Biotechnology facility in Limerick. This is a unique opportunity for an automation professional who enjoys combining hands‑on technical problem‑solving with quality and compliance activities within a GMP‑regulated manufacturing environment.

In this role, you will work closely with Manufacturing, Quality, Engineering, and Maintenance teams to provide technical and compliance support across critical manufacturing processes, with a key focus on MES. You will lead MES‑related deviation investigations, drive effective CAPA implementation, support change control activities, and help ensure ongoing system compliance and reliability.

As a trusted partner to cross‑functional teams, you will play an integral role in maintaining regulatory compliance, improving manufacturing performance, and delivering continuous improvement initiatives that support safe, efficient, and reliable operations across the site.

Key Responsibilities

• Act as the MES representative for related deviations, investigations, CAPAs and quality events.
• Lead and support the development, implementation, and closure of CAPAs arising from MES investigations.
• Collaborate with Quality, Engineering, Operations, and Maintenance teams to resolve automation compliance issues.
• Review and support MES‑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 MES 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.

Key Requirements

• Bachelors or Masters degree in Engineering, Computer Science, or related disciplines.
• 2+ years’ experience working with MES systems.
• 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.
• 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.