Validation Engineer

6 hours ago

Dublin, Ireland Ascend Project Management Full time

Client Services Manager | Life Science & EngineeringAscend PM are hiring a Validation Engineer to join our client team, a biopharmaceutical company based in Dublin.This is a great contract opportunity to join a growing team.Contact or email CV to to find out more.OverviewAn exciting opportunity has arisen for a Validation Engineer to support Tech Transfers/ New Product Introductions (NPI) within the Aseptic Process Validation team.The Validation NPI Engineer will support new product introductions from a Validation perspective and serve as the Validation SME for each new product transferred.The processes involved may be formulation, filling (vials & syringes), automated inspection and/or packaging for parenteral products.The completed Validation package will ultimately support the regulatory filing for that product.Key ResponsibilitiesAuthor and review regulatory documents (Section P.3.5)Provide technical input to assess validation impact to all the changes required for the new product/processAct as a responsible point of contact for the transfer project for Validation on the cross functional teamParticipate in full lifecycle of Product transfer: Attend Make a Batch reviews and provide validation inputChange Control Assessments: attend Stakeholder meetings, complete GDE documentation for validation teamDevelop, review and approve Validation plans protocols and reportsExecute Validation studies, document and investigate any discrepancies raisedSupport MES/EBR updatesSupport regulatory filings and RTQ's for validation as requiredEnsure Validation approach is based on the best available scientific evidence and professional judgment in collaboration with the Validation team.Support a robust fit for purpose transfer with quality designed into the processAssist with trouble shooting the equipment and advise cross-functional team on best qualification strategyDevelop and ensure internal policies, procedures and practices associated with the transfer are in compliance with Validation proceduresEnsure projects are executed safely, efficiently, and in accordance with all applicable codes and StandardsExperience & QualificationsMaster's degree with 5+ years of experience in validation, engineering or BS degree with 7+ years of experience in Validation, Engineering, Microbiology or QualityIn-depth understanding and application of validation principles, concepts, practices, and standardsIn-depth knowledge with cGxP as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturingExtensive working knowledge of sterilisation/decontamination systems and industry practicesExperience with Aseptic Process Simulation/Media FillExperience in Technical writing and translating complex process data, validation reports, and control strategies into clear, regulatory-compliant narrativesDemonstrate ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levelsSeniority levelMid-Senior levelEmployment typeContractJob functionPharmaceutical ManufacturingLocationDublin, County Dublin, Ireland#J-*****-Ljbffr

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