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: firstname.lastname@example.org
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