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Senior validation engineer

Galway
Collins McNicholas Recruitment
Validation engineer
Posted: 20 August
Offer description

Senior Validation Engineer – Contracting Opportunity!We are supporting an innovative early stage medical device company who are developing cutting-edge technology and are getting ready for FDA approval at their manufacturing site in Galway.To support development and manufacturing efforts, they require a Senior Validation Engineer on an initial 6-month contract to cover the validation activities with respect to the testing and manufacture of this new Medical Device product.Role/ Responsibilities:Develop, and/or approve, validation documentation, including protocol, records, and reports.Perform and oversee process and test method validation activities within the project.Execute process and test method validation activities in association with Operations, Quality Assurance, and R&D teams.Ensure that all validation activities are carried out and reported in a timely manner and in accordance with the project plan.Ensure compliance with current Good Manufacturing Practices (GMPs) and 21 CFR 820 requirements in all validation aspects.Communicate with all functional groups to ensure awareness of validation requirements.Investigate and troubleshoot validation problems which may occur and determine solutions.Communicate validation results and progress to management.As required, prepare summaries of validation testing for regulatory submissions and present validations to regulatory agencies.Qualifications & Experience:Bachelor's degree in an engineering, technology, or scientific discipline required with 5+ years’ experience in the medical device or pharmaceutical industry.Prior experience in the design and execution of process and test method validations.Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education.Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.Ability to work as part of a team and meet targets/goals efficiently.Demonstrated organizational, management, and communication skills.Good interpersonal & communication skills essential.
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