OverviewSenior Validation Engineer – Life Science and Engineering at Berkley Group. The Validation department performs equipment, utility, facility, cleaning, and sterilization validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing. This role focuses on delivering the qualification and validation program, including planning and execution of validation/requalification activities on critical facilities and equipment, with an emphasis on cleanroom environmental monitoring qualification to support changes and expansion of the production environment. There may be a requirement to work on shift to support critical project milestones.ResponsibilitiesProvide technical validation support to meet site objectives, comprising the full validation lifecycle process.Develop, review, and approve validation plans, protocols, discrepancies, and summary reports.Lead the strategy development and associated risk assessments for Environmental Monitoring qualification.Lead the planning and execution of environmental qualification activities in accordance with EU & FDA regulations including:Environmental Qualification of Grade C cleanroomsEnvironmental Qualification of Grade A Isolator Filling LinesSupport the execution of airflow visualization studies (smoke studies), filter integrity, velocity, and particle monitoring testing activitiesCoordinate projects and prioritize workload in line with site prioritiesParticipate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change controlCollate and report relevant validation data and metricsAssist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and Amgen standardsProvide validation support for Amgen's quality management system, including change control, deviation, and CAPA processesUpdate and maintain validation SOPs in accordance with site and corporate requirementsAttend and contribute to staff meetings and training sessions as requiredComply with the responsibilities outlined in the Site Safety Statement and champion safe working practicesPerform all tasks with due care and attention in accordance with Good Manufacturing Practices and Amgen's requirements, policies, and proceduresBasic QualificationsBachelor of Science/Engineering degree or equivalent. Microbiology qualification is desirableKnowledge of cGMPs and other worldwide regulatory requirementsProblem-solving ability and excellent oral and written communication skills5+ years' experience in a similar rolePreferred ExperienceExperience qualifying cleanroom facilities and/or HVAC systemsFamiliarity with Quality and Document Management Systems, including Maximo, Veeva, and KneatIndependent, self-motivated, proactive, organized, able to multi-task in project environments, and skilled in communication and collaborationSeniority levelMid-Senior levelEmployment typeContractJob functionConsulting and EngineeringIndustriesPharmaceutical ManufacturingDublin, County Dublin, Ireland
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