MES Automation Engineer - GMP, CAPA & Continuous Improvement

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

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.