KPC International - Excellence from Concept to CompletionKPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.We are looking to add an experienced intermediate CSV Engineer to join the team of our pharmaceutical client based in Tralee, Co Kerry.Key Responsibilities:Assisting in developing validation master plans and project-specific plans for computer systems.Creating essential quality documents like User Requirement Specifications (URS), Traceability Matrices, Test Protocols, and Validation Summary Reports.Executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) tests.Conducting risk assessments and impact analyses for systems and changes.Ensuring systems meet cGMP (current Good Manufacturing Practices) and data integrity standards.Working with IT, Quality Assurance (QA), Operations, and Maintenance teams.Managing validation for system updates and changes.Preparing for and participating in regulatory inspections (e.g., FDA, HPRA).Essential skills and QualificationsGood understanding of core pharmaceutical regulations, specifically FDA 21 CFR Part 11 (electronic records/signatures), EU Annex 11, and GxP (GMP, GLP, GCP) data integrity guidelines.Ability to perform risk assessments and impact analyses (e.g., using GAMP 5 principles) to identify critical functionalities and prioritize validation efforts effectively.Good understanding of data integrity principles (ALCOA+) and experience in implementing and remediating systems to ensure data traceability, transparency, and security.Good skills in technical writing for developing and maintaining validation documentation, including Validation Plans, requirements specifications, test scripts, traceability matrices, and summary reports.Experience in writing, reviewing, and approving Standard Operating Procedures (SOPs) related to CSV and ensuring adherence to internal quality management systems (QMS).Familiarity with change control processes, deviation management, and Corrective and Preventive Actions (CAPA) systems.Experience in participating in both internal audits and external regulatory inspections (e.g., by the FDA or EMA).Typically, a minimum of 3-5 years of relevant CSV experience within the pharmaceutical, biotech, or medical device industry.Strong analytical abilities to troubleshoot complex system issues, identify root causes, and propose effective solutions.Excellent verbal and written communication skills to effectively collaborate with cross-functional teams (IT, QA, Manufacturing, Lab personnel) and manage stakeholders at various levels.A meticulous approach to work, crucial for spotting errors and ensuring strict compliance in a highly regulated environment.KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.KPC – International is an Equal Opportunity Employer.LI-BC1