Validation Engineer
Sigmar Recruitment
Galway
About Your New Employer. They actively develop and introduce new medical technology and equipment for the diagnosis and treatment of disease, helping patients across the world to live longer, healthier lives! The Galway site has world class facilities and offers you the chance to work closely with leading edge technologies . This company offer an excellent salary and benefits package , including healthcare, bonus, matched pension contributions, flexitime, life insurance cover and excellent training and development. About Your New Job. You will report to the Senior Validation Engineer , working closely with product, with excellent opportunity to work collaboratively with different teams such as R&D, Manufacturing and Engineering. Coordinate testing, evaluate results and write validation plans and procedures. Help to improve and develop the validation program to ensure alignment with cGMP and industry standards. Help to specify, install, validate, troubleshoot and maintain equipment and systems. Work closely with Manufacturing and Automation Engineering in the design, documentation , and performance and improvement of process validations. Assist software system developers and subject matter experts in designing, documenting, performing, and improving verification tests. Offer consultation to other teams on computer system validation requirements at early project stages. What Skills You Need. A Level 8 or higher degree in an engineering or science. 2-3 years of related experience withing medical device or pharma. Experience in of quality systems , process controls and continuous improvement. Expertise in Microsoft Office applications, e.g. Word, Outlook, Excel. Knowledge of Minitab and statistics. Knowledge of database systems, PLC methodologies /systems and ERP. Knowledge of regulations and standards such as ISO24485 , FDA (21CFR11), GAMP5, PDMA , etc. Experience of validation principles, risk assessments, CAPA, change control. Why Apply Through Sigmar? We’ll help manage your job hunt , strengthen your interview skills and tidy up your CV. We’ll provide you with an overview of the jobs market within your industry and help you tailor your job search. You will gain access to exclusive roles that are not advertised elsewhere. To apply for this job please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E: koshea@sigmar.ie. All applications to this job will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent.
919 days ago