Validation Specialist

2 weeks ago

Dundalk, Ireland Green Fox Selection Full time

About You:Bachelor's degree in Science, Engineering, Technology or a related discipline.1-2 years of hands-on experience working as a validation engineer/specialist in a GMP environment,Experience within a similar role – with focus on validation projectsKnowledge of HVAC/Refrigeration systems including automation.Excellent communication skills including ability to present technical information to non SMEaudience.Committed to deliver outstanding customer service.A self-starter who can drive long-term objectives.Ability to gather, understand, analyse and interpret information and concepts quickly.Experience in end-to-end qualification.Developing URS, IQ/OQ/PQ.ResponsibilitiesGeneration, execution and close out of validation projects relating to existing products and new product introductions.Participate in project teams and assist in determining project schedules and the appropriate levels of validation.Execution and documenting risk assessments with respect to validation activities.Investigate, track and resolve deviations during qualification activities.Proactively supports their direct Supervisor to successfully achieve departmental and site objectives and undertake assigned projects.Adopts positive cross functional relations.Assess validation requirements (new equipment, change controls, etc.), monitor project status, and ensure timely updates.Maintain validation status through monthly reports and meetings, collaborating with project managers to adhere to schedules.Ensure GMP compliance, stay updated on validation innovations.Generate and execute validation protocols, review project change controls, and prepare necessary documentation and reports.Contribute to developing company validation standards and assist with department growth as needed.Present professionally to management and auditors, support processes, and address queries during regulatory inspections.Liaise with relevant Q.A. personnel to complete project documentation within defined time frames

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