Engineering Compliance Specialist

QCS Staffing Ltd; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

QCS Staffing Ltd in Dublin seeks an Engineering Compliance Specialist on an 11-month contract to support pharmaceutical manufacturing. The role focuses on deviations, QNs, CAPAs and investigations within a GMP framework, ensuring compliant engineering documentation and timely actions.

You will perform root cause analysis, implement corrective actions, and assist with change controls. Experience in GMP-regulated environments and readiness for audits/inspections is required.

Qualifications

• Experience handling deviations, investigations and CAPAs in GMP environments.
• Strong RCA skills to identify root causes and implement preventive actions.
• Knowledge of cGMP requirements and regulatory expectations.
• Experience supporting audits, inspections and readiness activities.

Responsibilities

• Lead and support engineering-related deviations, QNs, CAPAs and investigations.
• Conduct root cause analysis and implement corrective and preventative actions.
• Review and maintain GMP engineering documentation and electronic logs.
• Support change controls and ensure timely documentation.

Skills

Deviations mgmt

CAPA

Root cause analysis

GMP knowledge

Audits & inspections

Job description

Engineering Compliance Specialist – Dublin, Ireland – Initial 11-Month Contract – Life Scientist

Our client is a global leader in pharmaceutical innovation, specialising in the development and manufacture of cutting-edge drugs. As they continue to grow, they’re seeking an experienced Engineering Compliance Specialist to support their dynamic team and drive forward groundbreaking projects near Dublin.

What you’ll deliver:

• Lead and support engineering-related deviations, quality notifications (QNs), CAPAs, and investigations.
• Conduct root cause analysis (RCA) and implement effective corrective and preventative actions.
• Review and maintain engineering GMP documentation and electronic logs.
• Support engineering change controls and ensure documentation is completed in a timely manner.

What you’ll need:

• Previous experience within a GMP-regulated pharmaceutical, biotech, or medical device manufacturing environment.
• Experience managing deviations, investigations, CAPAs, change controls, and quality systems documentation.
• Strong understanding of cGMP requirements and regulatory compliance.
• Experience supporting audits, inspections, and inspection readiness activities.