Senior Validation Specialist

Job DescriptionIf you are a current Jazz employee please apply via the Internal Career site.nJazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to ntransform the lives of patients and their families. We are dedicated to developing nlife-changing medicines for people with serious diseases often with limited or no ntherapeutic options. We have a diverse portfolio of marketed medicines, including leading ntherapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. nOur patient-focused and science-driven approach powers pioneering research and development nadvancements across our robust pipeline of innovative therapeutics in oncology and nneuroscience. Jazz is headquartered in Dublin, Ireland with research and development nlaboratories, manufacturing facilities and employees in multiple countries committed to nserving patients worldwide. Please visitnwww.jazzpharmaceuticals.comnfor more information.n Reporting to the Engineering department, this role will support delivery of the Site Validation Master Plan (SVMP) Schedule, overseeing validation/ qualification activities across the Jazz KSP site including manufacturing plant equipment, laboratory analytical equipment and utility/ facility qualification, ensuring compliance with Jazz procedures, Regulatory requirements and GMP (Good Manufacturing Practice).Essential Functions/ResponsibilitiesTo generate validation/ qualification documentation (following Jazz templates/ procedures) associated with manufacturing plant equipment, laboratory analytical equipment and utilities/ facilities across commercial and development space. This will include routine requalification works (as per periodic evaluation of systems) as well as introduction of new equipment (supporting Capital Project team).If a vendor is authoring validation documentation (e.g. FAT, SAT, IQ etc), to review / approve documentation.To lead/ support execution of validation/ qualification activities in collaboration with system owning department.Visit equipment vendor facilities to execute FAT (Factory Acceptance Test) as required.Manage activities as per the SVMP and report progress via the SVMP.Manage third party suppliers with respect to qualification and validation activities (where required).Provide SME impact assessments for change controls involving validation/ qualification activities.Own and deliver Change Actions and CAPAs within eQMS for validation/ qualification activities.Lead deviations related to qualification incidents.Support equipment decommissioning activities as required.Matrix manage teams as required to deliver a validation project.Required Knowledge, Skills, and Abilities 5+ years relevant work experience in the pharmaceutical, biotechnology or related industry where principles of GMP applyAn appreciation of validation principlesExperience in technical writing, and good knowledge of Microsoft Office IT packages (Word, Excel, Powerpoint).Ability to collaborate across cross functional teams, and matrix manage teams for delivery of a validation project.Excellent communication skillsRequired/Preferred Education and LicensesA bachelors degree in science, engineering or related discipline (preferred)Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.

Created: 2025-09-11