Dunleary - Sr Automation Validation Engineer

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As a senior automation validation engineer, you will be responsible for ensuring that the Automation of Process, Equipment and Systems of the Site are in compliance with Division Quality System requirements and recognised international standards. Major Responsibilities • Development of Validation Plans, Installation Qualifications (IQs), Operational Qualifications (OQs), Process Qualifications (PQs), and System Certification Summaries.• Leading the team to ensure all aspects of activity within the Validation group adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures. • Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective. • Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Tests (Fat’s) and any other associated validation issues. • Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. ...

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