Quality Engineer, Pharma Manufacturing (IQ/OQ/PQ, CAPA)

Myn; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

Myn in Ireland is seeking a Quality Engineer to provide technical quality engineering support across manufacturing operations, focusing on equipment/process qualification, deviations, CAPA, and validation activities. This hands-on role requires experience in a GMP environment with minimal ramp-up time.

You will work with Manufacturing, Engineering, Validation and Regulatory Affairs to resolve quality issues, support audits, and maintain quality metrics and risk assessments.

Qualifications

• Degree in a relevant scientific or engineering discipline.
• Experience as Quality Engineer in pharma/biopharma/medical devices manufacturing.
• Strong knowledge of EU GMP and HPRA.
• Experience with deviation, CAPA, change control and root cause analysis.
• Experience with IQ/OQ/PQ documentation and execution.
• Available to start on short notice.

Responsibilities

• Support equipment, utility, and process qualification activities (IQ/OQ/PQ).
• Investigate deviations/non-conformances with root cause analysis.
• Author, implement, and track CAPAs through closure.
• Support change control, assess quality impact of changes.
• Review and approve batch records, protocols, quality records for GMP compliance.
• Assist audits and regulatory inspections with technical input.
• Conduct risk assessments (e.g., FMEA) for processes and changes.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory Affairs to resolve quality issues.

Skills

Root cause analysis

CAPA management

Change control

IQ/OQ/PQ

GMP compliance

Regulatory inspections

QMS software

Documentation

Education

Science/Engineering degree

Tools

TrackWise

MasterControl

Veeva

Job description

Myn in Ireland is seeking a Quality Engineer to provide technical quality engineering support across manufacturing operations, focusing on equipment/process qualification, deviations, CAPA, and validation activities. This hands-on role requires experience in a GMP environment with minimal ramp-up time.

You will work with Manufacturing, Engineering, Validation and Regulatory Affairs to resolve quality issues, support audits, and maintain quality metrics and risk assessments.