PE Global is currently recruiting for an Engineering Validation Technician for a leading multi-national Biotech client based in Cork.This is an initial 12-month contract position working on days.ROLE:In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process Validation programs.Execute (protocol generation, execution, and final package preparation) Validation activities related to the various Validation disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change Control.Develop validation plans for specific system implementation projects.Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance.Assist with preparation of regulatory filings and participation during regulatory inspections/partner audits.Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by client, validation techniques/approaches and systems utilized at siteLead and represent validation in multi-departmental meetings and project teams.Identifies and implements improvements to the Engineering Validation systems.Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.Other duties as assigned.REQUIREMENTS:Bachelor's degree (Level 8 or equivalent) in Engineering, Biotechnology, Biochemistry, Pharmaceutical Science, Chemical Engineering, or a related life-sciences discipline, providing a strong foundation in manufacturing processes, validation principles, data analysis, and regulatory compliance.Minimum 5 years' experience in Engineering Validation within a GxP-regulated environment. Proven hands-on experience executing validation activities in biopharmaceutical, pharmaceutical, biotechnology, or medical device manufacturing, including equipment, utilities, facilities, laboratory systems, and/or process validation.Strong background in Commissioning, Qualification, and Validation (CQV). Demonstrated experience generating and executing validation protocols (IQ/OQ/PQ), preparing final validation packages, and supporting FUE qualification, CSV, New Product Introductions (NPI), and Change Control activities.Solid understanding of regulatory and compliance requirements. In-depth working knowledge of cGMP, GxP, FDA, EMA, ICH, and data integrity requirements, with experience supporting regulatory inspections, partner audits, and preparation of regulatory submission documentation.Experience managing deviations, change controls, and CAPAs Ability to prepare, track, and close change requests, deviations, quality events, and CAPAs in collaboration with Quality and cross-functional stakeholders, ensuring compliance and timely resolution.Strong cross-functional collaboration and technical leadership skills. Experience leading or representing validation in multi-department project teams, coordinating activities across Manufacturing, Quality, Process Sciences, Engineering, IT/CSV, and Regulatory Affairs, with the confidence to drive validation deliverables to completion.