Asset Recruitment Ltd

MES Validation Engineer (BB-39874)

Found in: Neuvoo IE

MES Validation Engineer- DublinAn exciting new contract position has arisen for an experienced MES Validation Engineer to join our West Dublin based client; a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care providing therapeutic solutions for unmet medical needs through differentiated and innovative medicines in oncology, neurosciences and rare diseases.ROLEThe Validation Engineer (MES) will report to the Validation Manager, perform all required Validation activities and oversee validation activities for the implementation of Manufacturing Execution System (MES) in compliance with all appropriate cGMP regulations and guidelines.RESPONSIBILITIESPerform Validation role in development /implementation process of Manufacturing Execution System (MES) project.Review of MES documentation, recipes and process flows; supporting MES change controlEnsure design and validation of the MES system meets cGxP, Data Integrity and site requirementsReview and approval of MES design documentsAuthoring, review, approval, execution of MES validation documentsCoordination of MES Validation activities performed by Quality, IT and Manufacturing functions• Other activities deemed necessary by the Validation ManagerEXPERIENCE / QUALIFICATIONS3 years Validation experience including previous MES experience.Third Level Qualification in Science related disciplineKEY TECHNICAL COMPETENCIES:Knowledge of cGMP as it relates to API (Requirements of EMEA, FDA and ICH)Work with minimal supervisionPerform under pressure to competing demands and stakeholders with strong customer focus.Perform work with highest levels of confidentiality and integrity.In-Depth knowledge of Quality Systems and their maintenance / implementation in API sitesTeam-working and communication skills

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location_onDublin, Ireland

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