Validation Engineer

QCS Staffing; Carlow; On-site; EUR 55,000 - 75,000; Full time

Job summary

QCS Staffing is seeking a Validation Engineer for an initial 11‑month contract in Carlow, Ireland. The role focuses on validation of equipment and processes in a GMP environment, supporting QA and regulatory compliance, and driving validation strategies across projects.

You will work with cross‑functional teams to ensure robust qualification plans, root‑cause analyses, and timely resolution of deviations, while maintaining high documentation standards and contributing to audits and inspections.

Qualifications

• Experience in equipment and process validation within GMP environments.
• Knowledge of CTU qualification, thermal mapping, sterilisation (VHP, autoclave, SIP, dry heat) and sterile fill‑finish equipment.
• Ability to analyse complex technical data, perform root cause analyses, and relate findings to equipment or process performance.
• Strong communication and leadership skills, with experience writing high‑quality reports and coordinating across global teams.

Responsibilities

• Design, review, approve, and execute qualification/validation documentation and studies to meet GMP/regulatory standards.
• Troubleshoot and resolve issues during validation activities, performing root cause analysis.
• Collaborate with Production, Maintenance, and Quality teams and act as validation representative for projects and global forums.
• Support audits/inspections, complete risk assessments, and close out corrective actions.

Job description

Validation Engineer – Carlow, Ireland – Initial 11-Month Contract – Life Sciences

Our client is a global leader in pharmaceutical innovation, specializing in the development and manufacture of cutting‑edge drugs. As they continue to grow, they’re seeking an experienced Validation Engineer to support their dynamic team and drive forward groundbreaking projects in Carlow.

What You’ll Deliver

• Design, review, approve, and execute qualification/validation documentation and cycle development studies, ensuring they meet GMP and regulatory standards.
• Troubleshoot and resolve technical issues during studies, performing root cause analysis to address equipment or system failures.
• Work closely with Production, Maintenance, and Quality teams and act as the validation representative for projects and global technical forums.
• Ensure full cGMP compliance, support audits and inspections, complete documentation and risk assessments, and close out corrective actions.

What you’ll need:

• Experience in equipment and process validation, deviation/exception management, change control, and working within GMP‑regulated environments.
• Knowledge of CTU qualification, thermal mapping, sterilisation (VHP, autoclave, SIP, dry heat), isolators, and sterile fill‑finish equipment.
• Ability to analyse complex technical data, perform root cause analysis, and link findings to equipment or process performance.
• Strong communication, ability to lead technical projects, and high‑quality report/policy writing, collaborating with Quality, Maintenance, Production, and global teams.