QA Validation Engineer – LIMS, Lab Equipment & CSV

Ensure every system is launch‑ready-lead validation excellence for a fast‑moving pharma site in Tipperary.

R&D Partners is seeking a QA Validation Specialist for an immediate start on a 12-month contract to support validation activities related to Laboratory Information Management Systems (LIMS), analytical lab equipment, and computerized systems within a GMP-regulated pharmaceutical environment. This role is critical in ensuring data integrity, system compliance, and readiness for commercial operations as the company prepares to launch two products by year-end.

This is an onsite position based in Tipperary.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Review and approve validation documentation (IQ/OQ/PQ) for LIMS, lab instruments, and computerized systems.
• Provide QA oversight during execution of CSV and equipment qualification activities.
• Support the development and maintenance of the Computer System Validation Master Plan and related documentation.
• Ensure validation activities comply with GAMP 5, Annex 11, and 21 CFR Part 11 requirements.
• Collaborate with QC and IT teams to ensure proper system configuration, data integrity controls, and audit trail functionality.
• Lead or support investigations and CAPAs related to lab system validation deviations or issues.
• Review and approve SOPs, protocols, reports, and technical documentation for lab systems and equipment.
• Participate in risk assessments and data integrity reviews for lab systems.
• Support internal and external audits, acting as SME for CSV and lab equipment validation.

Key Skills and Requirements:

• Degree in a scientific or technical discipline (e.g., Computer Science, Life Sciences, Engineering).
• Minimum 5 years of experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Proven experience in CSV, LIMS validation, and lab equipment qualification.
• Strong understanding of GAMP 5, Annex 11, and 21 CFR Part 11 compliance.
• Excellent documentation, communication, and cross-functional collaboration skills.
• Experience supporting audits and inspections as a validation SME.

For more information, please contact Billy O’Brien.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you’ve read and understood our privacy policy, which informs you how we process and safeguard your data – https://www.r-dpartners.com/privacy-policy/