OverviewJoin to apply for the Validation Manager role at Eirdata Environmental Services Ltd.About the CompanyEstablished in 2001, Eirdata are specialists in cleanroom validation, commissioning and compliance. We provide these range of services to the pharmaceutical, medical devices and healthcare sectors primarily. In 2013, Eirdata was acquired by ESS Ltd. Engineering, Support & Services (ESS) Ltd. We work with our people to implement and carry out maintenance and asset management to optimise performance.ESS Group includes three companies – Engineering Support & Services Ltd. (ESS), Eirdata Environmental Services Ltd. (Eirdata), and the newly joined Critical Airflow Europe (CAE).ESS are experts in asset management and maintenance reliability through people.Eirdata are specialists in cleanroom validation, commissioning and compliance, HVAC systems, indoor air quality and building wellness.CAE are the European leader in delivering safe energy efficient laboratory control and critical airflow applications. Critical Airflow Europe Ltd represents Phoenix, Strobic.Position OverviewThe Validation Lead is responsible for overseeing the planning, coordination, and execution of validation activities within the organization. This includes ensuring compliance with regulatory standards, internal quality policies, and project requirements. The role also involves the development and implementation of validation procedures, generating comprehensive reports, and supporting tender submissions by providing detailed validation documentation. The Validation Lead will play a key role in offering technical validation support across projects, managing follow-ups to ensure timely closure of validation activities, and driving process improvements to enhance operational efficiency and compliance. Additionally, the role supports the development and growth of the business, working closely with the General Manager, Operations Manager, and HVAC Services Lead to achieve strategic objectives.ResponsibilitiesDevelop, manage, and execute validation plans, protocols (IQ, OQ, PQ), and reports in compliance with regulatory and industry standardsLead validation efforts for HVAC equipment, facilities, lab equipment and utilities systemsCollaborate with client cross-functional teams (e.g., Quality Assurance, Engineering, Manufacturing) to define and execute validation requirementsMaintain up-to-date knowledge of applicable regulations (e.g., FDA, EU GMP, ISO 14644) and ensure validation activities align with themIdentify and resolve validation-related issues, providing risk assessments and remediation plans as neededOversee the development and training of the validation team, ensuring high standards of competency and complianceConduct annual reviews for the teamProvide technical validation support for tender processes, including preparing and reviewing validation documentation as part of bid submissionsConduct validation follow-ups to ensure all identified actions and non-conformances are closed in a timely and compliant mannerCreate and refine validation procedures to align with regulatory and internal standards, ensuring repeatability and efficiencyManage validation project timelines, budgets, and resources effectivelyDrive continuous improvement initiatives within validation processes to enhance efficiency and complianceAct as the primary point of contact for internal and external audits concerning validation activitiesEnsure company validation, calibration and maintenance records are maintainedEducation & QualificationsRelevant Engineering Qualification i.e., Level 7 or Level 8 MechanicalRequired SkillsMinimum of 5 years working within a Lead role within a regulated environmentExperience in a GMP manufacturing environmentProficient in Microsoft Office (Excel, Word, PowerPoint)Excellent communication skills, a confident and effective decision maker, with a proven ability to influence othersTeam player, with a flexible approach but also able to work under own initiativeStrong verbal and interpersonal skillsCompetent level of technical writing and understanding of technical documentationFull clean driving licenceMust be eligible to work in IrelandSeniority levelNot ApplicableEmployment typeFull-time
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