Headcount Solutions Limited

Process Engineer (BB-7B778)

Found in: Neuvoo IE

Headcount Solutions is seeking a Process Engineer for our client’s expanding biopharma facility. As part of the Technical Transfer team the Process Engineer will be responsible for the transfer of a syringe and/or vial commercial product from existing lines to the expanded facility, as well as the transfer of a formulation process from a US site.Main Responsibilities: * Execute process engineering activities to support the technical transfer of products to site. This includes: engineering studies, equipment tuning, development batches, single use component fit checks, process simulations, PPQ’s, etc. * Provide input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met. * Provide technical and product guidance to the process, design and project delivery teams. * Author and review procedures and technical reports as required as part of the technical transfer. * Review and approve Validation protocols executed by vendors, cross functional groups and/ or validation counterparts. * Lead and support component criticality assessments for the process and create control strategies. * Execute activities as part of the Change Management process for the product introduction. * Represent the site in internal collaborations with Technical Transfer and Commercialization teams to include sharing of best practices.Requirements * Degree qualification in a relevant engineering discipline. * Minimum of 2 years directly related experience in academia, pharmaceutical or biotechnology industry. * Experience with sterile processing and sterilisation technologies * Ideally - prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection. * Desirable - familiarity with equipment within a sterile fill finish environment e.g. CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels, Vial / Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.For further information, please contact Mick

calendar_today1 hour ago

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location_onLeinster, Ireland

work Headcount Solutions Limited

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