Validation Engineer

OverviewWould you like to join an international team working to improve the future of healthcare?Do you want to enhance the lives of millions of people?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 summaryPOSITION SUMMARY:The 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 to focus on the areas of 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 FDA.Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.Supporting 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 standards.Demonstrates technical knowledge and ability to adapt to changing circumstances.Works with other departments Operations, Quality, and Maintenance to execute qualification and validation efforts in support of site projects.Completion of risk assessments, closure of corrective and preventive actions (CAPAs).Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements.Performs other validation associated activities as defined by Manager or Director.Key competenciesPackaging Equipment QualificationTemperature MappingComputer System ValidationClean UtilitiesCleaning Validation, preferableCommissioning and QualificationDocumentation (Writing SOPs, Protocols, Reports)AuditingStrong communication / presentation skills during internal/external audits.Person specificationProject 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 skills.Familiarity with cGMPs and industry and federal guidelines required.Experience with Word, Excel and Access computer applications.Strong interpersonal skills for interactions with other departments.Degree in Science/Engineering and/or Min 4 years Validation experienceExperience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) auditsWorking knowledge of HTM 01 (Part C, Steam Sterilization) AutoclavesFamiliarity with ISO-***** (Cleanrooms and Associated Environments)Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products)Experience within aseptic manufacturing environmentBenefitsHighly competitive salaryGroup pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will matchPrivate Medical Insurance for the employeeOngoing opportunities for career development in a rapidly expanding work environmentSuccession planning and internal promotionsEducation allowanceWellness activities - Social activities e.g. Padel, Summer 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#LI-FD1Grange Castle International Business Park, Grange, Co.Dublin, D22 K2R3Learn more about GrifolsReq ID:Type:Regular Full-TimeJob Category:#J-*****-Ljbffr