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Validation Engineer

Posted on Sep 21, 2020 by CV-Library

Dublin, City of Dublin, Ireland
Engineering
Immediate Start
Annual Salary
Contract/Project

Validation Engineer Headcount Solutions is sourcing a Senior Validation Engineer for our clients biotech facility in Dublin. This person will provide Validation oversight of external manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation activities. The role will be working from home until Covid restrictions are lifted, site visits will be required 2021 (CMO sites are Germany, TBC). Key Responsibilities: * Translate client requirements into the language of the CMO - can make a risk-based decision. * Validation document author/approver. * Ensure validated parameters are correctly incorporated in Master Batch Records. * Regulatory - aseptic processing system oversight (media fill, autoclave validation, EM) content authorship. * Validation change control assessment. * Perform Person in Plant activities as required. * Author applicable MA filing sections. * Write/review RTQs. * Determine validation strategy and outcome of validation activities. * Decision to approve or reject validation documentation. * Provide Validation position on related topics and strategy for the site. Requirements: * Degree qualified in science and/or engineering. * Ideally 8 years+ biotech or pharmaceutical industry experience. * Significant Validation experience at Aseptic Manufacturing or API facilities. Validation experience - (manufacturing process validation, NPI all the way through to PPQ) * Familiarity with basic project management tools. * Ability to negotiate a strategic position after taking feedback from multiple sources (dealing with CMOs, communicate with others where English isn't first language). * Strong project management, problem-solving, and analytical skills. * Ability to operate in a matrixed or team environment with site, functional, and executive leadership. For further information please contact Mick on (phone number removed) or forward details in confidence to [email protected]


Reference: 212471713

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