Job Description

Job Advertisement: CSV Engineer / Specialist

Location: Ireland
Contract: 12-month renewable contract

Overview

We are seeking a dedicated and experienced mid-level Computer System Validation (CSV) Engineer to join our team. This role involves supporting GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. The successful candidate will focus on the hands-on execution of CSV lifecycle activities, collaborating closely with Quality, Engineering, IT, and project teams to ensure compliance and timely project delivery.

Key Responsibilities

• Execute CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipment.


• Prepare and support CSV documentation such as Validation Plans, URS, Risk Assessments, IQ, OQ, PQ, and final reports.


• Apply risk-based validation approaches for both new and existing systems.


• Ensure compliance with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11 regulations.


• Support project teams to align validation activities with delivery timelines.


• Participate in validation risk assessments and define testing scope.


• Review system specifications, design documents, and qualification records.


• Support deviation management, discrepancy resolution, and data integrity assessments.


• Assist with periodic system reviews, audits, and regulatory inspections.


• Support the development and maintenance of CSV and qualification SOPs.


• Collaborate with cross-functional and global CSV teams.


• Escalate quality or compliance risks as required.


• Adhere to EHS and site safety procedures during validation activities.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline.


• 4–7 years of experience in Computer System Validation within the pharmaceutical or biopharmaceutical industry.


• Strong understanding of CSV regulations and quality expectations.


• Hands-on experience validating GAMP Category 3, 4, and 5 systems.


• Proven experience executing validation protocols and managing validation documentation.


• Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines.


• Experience supporting investigations, root cause analysis, and CAPAs.


• Strong documentation skills and the ability to collaborate effectively across functions.

If you are a motivated professional with a passion for ensuring compliance and quality in GMP-regulated environments, we encourage you to apply for this exciting opportunity. Join us and contribute to the success of our projects while advancing your career in Computer System Validation.