Instrumentation Engineer — GMP Compliance & QC Oversight

Aphex Group; Carlow; On-site; EUR 60,000 - 90,000; Full time

Job summary

Aphex Group in Ireland seeks a QC Systems & Instrumentation professional to ensure cGMP compliance and drive continuous improvement across laboratory instrumentation. You will oversee external calibration activities, coordinate audits and lead cross-functional projects to enhance lab capability.

The role requires a degree in Chemistry/Science, strong data integrity knowledge, and Lean Six Sigma experience, with proficiency in MS Office and vendor management. On-site in Carlow, Ireland.

Qualifications

• Bachelors degree or higher, ideally in Chemistry/Science or related discipline.
• Experience in a Manufacturing/Laboratory environment, preferably GMP.
• Knowledge of cGMP and GDP preferred.
• Knowledge of data integrity requirements.
• Proficiency in Microsoft Office and related applications.
• Lean Six Sigma methodology experience desired.

Responsibilities

• Drive compliance with cGMP, GDP and global policies in day-to-day activities.
• Provide technical oversight for external vendor calibration PM/OQ activities.
• Lead day-to-day oversight for external vendors and collaboration with suppliers.
• Facilitate communication to ensure testing and validation activities stay on schedule.
• Coordinate audits and inspections, supporting readiness and compliance.
• Review instrumentation lifecycle, commissioning and qualification documents.
• Lead continuous improvement and root cause analysis for equipment issues.
• Represent QC in site projects and cross-department initiatives.
• Manage resources for improvement ideas and merit-based projects.

Skills

Data integrity

cGMP knowledge

GDP knowledge

Microsoft Office

Lean Six Sigma

Education

Bachelor's degree or higher in Chemistry/Science or related

Job description

Aphex Group in Ireland seeks a QC Systems & Instrumentation professional to ensure cGMP compliance and drive continuous improvement across laboratory instrumentation. You will oversee external calibration activities, coordinate audits and lead cross-functional projects to enhance lab capability.

The role requires a degree in Chemistry/Science, strong data integrity knowledge, and Lean Six Sigma experience, with proficiency in MS Office and vendor management. On-site in Carlow, Ireland.