Quality Engineer — Pharmaceutical Manufacturing, Ireland (Contract)

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

Role Overview

The successful candidate will provide technical quality engineering support across manufacturing operations, with a focus on equipment/process qualification, deviation investigation, CAPA, and validation activities. This is a hands-on, execution-focused role suited to an experienced Quality Engineer who can be effective quickly in a GMP manufacturing environment with minimal ramp-up time.

Role Overview

The successful candidate will provide technical quality engineering support across manufacturing operations, with a focus on equipment/process qualification, deviation investigation, CAPA, and validation activities. This is a hands-on, execution-focused role suited to an experienced Quality Engineer who can be effective quickly in a GMP manufacturing environment with minimal ramp-up time.

Key Responsibilities

• Support equipment, utility, and process qualification activities (IQ/OQ/PQ), ensuring documentation meets GMP and regulatory requirements.
• Investigate deviations and non-conformances, applying structured root cause analysis (e.g. 5 Whys, Fishbone/Ishikawa, FMEA) to identify true root cause.
• Author, implement, and track CAPAs (Corrective and Preventive Actions) through to effective closure.
• Support change control activities, assessing the quality impact of proposed changes to processes, equipment, or documentation.
• Review and approve batch records, protocols, and quality records, ensuring accuracy and GMP compliance.
• Support internal and external audits, including supplier quality audits and regulatory inspections, providing technical quality input as required.
• Conduct and document risk assessments (e.g. FMEA) for processes, equipment, and changes.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory Affairs to resolve quality issues and support continuous improvement.
• Maintain quality metrics and trend data, identifying and escalating emerging risks.
• Ensure all work is conducted in compliance with EU GMP, HPRA requirements, and site EHS standards.

Essential Qualifications & Experience

• Degree in a relevant scientific or engineering discipline (chemistry, biology, chemical/mechanical engineering, or related field).
• Demonstrable experience in a Quality Engineer or similar hands-on quality role within pharmaceutical, biopharmaceutical, or medical device manufacturing.
• Strong working knowledge of EU GMP and HPRA regulatory requirements.
• Practical experience with deviation/CAPA/change control systems and root cause analysis methodologies.
• Experience with equipment/process qualification (IQ/OQ/PQ) documentation and execution.
• Available to start within a short notice period, given the contract nature of the role.

Desirable Criteria

• Experience specific to the site's product type (e.g. sterile/aseptic manufacturing, biologics, oral solid dose, or combination products).
• Six Sigma / Lean qualification, or demonstrable continuous improvement project experience.
• Prior contract/interim experience, with the ability to add value quickly in an unfamiliar site environment.
• Experience with electronic QMS platforms (e.g. TrackWise, MasterControl, Veeva).
• Direct experience supporting HPRA or FDA regulatory inspections.

Person Specification

• Strong analytical and problem-solving skills, with a methodical approach to root cause investigation.
• Self-sufficient and effective from day one, able to integrate quickly into an established quality team.
• Excellent written communication skills, particularly for technical documentation and investigation reports.
• Detail-oriented, with a strong sense of ownership over quality outcomes.
• Collaborative team player, comfortable working cross-functionally with Manufacturing and Engineering colleagues.