Laboratory Analytical Specialist

QCS Staffing Ltd; Carlow; On-site; EUR 41,000 - 76,000; Full time

Job summary

QCS Staffing Ltd in Carlow, Ireland, is seeking a Laboratory Analytical Specialist for an initial 11-month contract. The role focuses on qualification/validation documentation, cycle development, and ensuring cGMP compliance within a GMP-regulated environment.

You will support audits, perform root cause analysis, and collaborate with Production, Maintenance, and Quality teams. The ideal candidate has strong experience in equipment validation, CTU qualification, sterile fill-finish

Qualifications

• Experience in equipment and process validation within GMP-regulated environments.
• Ability to analyse complex technical data and link findings to performance.
• Strong communication and collaboration with cross-functional teams.

Responsibilities

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

Skills

GMP compliance

Root cause analysis

Technical project leadership

Technical report writing

Job description

Laboratory Analytical Specialist - Carlow, Ireland - Initial 11-Month Contract - Life Sciences 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 Laboratory Analytical Specialist 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.