Validation Engineer

Get AI-powered advice on this job and more exclusive features.Would you like to join an international team working to improve the future of healthcare?Grifols is a global healthcare company that since **** has been working to improve the health and well-being of people around the world.We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.At Grifols, we believe that diversity adds value to our business, our teams, and our culture.We are committed to equal employment opportunities that foster an inclusive environment.Position SummaryThe Validation Engineer will write, review and execute Validation Plans, Protocols and Reports for Secondary Packaging Projects and Revalidations ensuring compliance to all relevant global and local quality and validation procedures/standards.Initial requirements focus on Packaging Equipment Qualification and Temperature Mapping with Utilities, Cleaning Revalidation to follow.Represent Validation at technical forums including external and internal audits.ResponsibilitiesWrite, review and execute Validation Protocols and Reports (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standardsRepresent Validation at both internal and external audits by regulatory agencies, including HPRA and FDAGeneration and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating ProceduresSupport validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standardsDemonstrates technical knowledge and ability to adapt to changing circumstances.Works with Operations, Quality, and Maintenance to execute qualification and validation efforts in support of site projectsCompletion of risk assessments, closure of corrective and preventive actions (CAPA)Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvementsPerforms other validation-associated activities as defined by Manager or DirectorKey competenciesPackaging Equipment QualificationTemperature MappingComputer System ValidationClean UtilitiesCleaning ValidationCommissioning and QualificationDocumentation (Writing SOPs, Protocols, Reports)AuditingStrong communication / presentation skills during internal/external auditsPerson specification / QualificationsProject Management ExperienceHands-on knowledge of execution of ValidationExperience in a Quality or Validation Role within Pharma sectorExperience with Software validation for manufacturingExcellent Technical Writing and analytical skillsFamiliarity with cGMPs and industry/federal guidelinesExperience with Word, Excel and AccessStrong interpersonal skills for interactions with other departmentsDegree in Science/Engineering and/or minimum 4 years Validation experienceExperience representing client companies during internal and external audits (FDA/HPRA)Working knowledge of HTM 01 (Part C, Steam Sterilization) AutoclavesFamiliarity with ISO-***** (Cleanrooms) and Annex 1 (Sterile Manufacturing)Experience within aseptic manufacturing environmentOur benefitsHighly competitive salaryGroup pension scheme with company matchingPrivate Medical Insurance for the employeeOngoing opportunities for career developmentSuccession planning and internal promotionsEducation allowanceWellness activities and social eventsWe understand that self-doubt can hold talented individuals back from applying for opportunities.We encourage everyone who meets the qualifications to apply – we're excited to hear from you.Grange Castle International Business Park, Grange, Co.Dublin, D22 K2R3DetailsSeniority level: Mid-Senior levelEmployment type: Full-timeJob function: Quality AssuranceIndustries: Pharmaceutical Manufacturing and Medical Equipment ManufacturingLearn more about Grifols#J-*****-Ljbffr