What you need to know

Our client who provides innovative products and services to many of the world’s largest medical device and pharmaceutical companies is currently looking for an experienced and committed Validation Engineer to join its team in Galway City.

As a Validation Engineer, you will report directly to the Technical Services Manager and work with them collaboratively to support the development and implementation of new equipment and processes.

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This is a permanent role with an excellent salary and package that includes 25 days annual leave, company pension, bonus, life assurance, healthcare for you and your family and training and development opportunities.

Your new job

Key duties & responsibilities:

• Support laboratory equipment procurement and develop URS documentation.

• Work as a team to create, execute, and report on IQ, OQ and PQ protocols.

• Development of equipment related instructions and forms where required.

• Generate equipment measurement uncertainty budgets.

• Training of personnel in use of equipment and related documented instructions and forms

• Design and execute Test Method Validation studies using appropriate approach (e.g., variable, variable destructive, or attribute Gauge R&R)

• Establish statistically valid Test Method Validation sample sizes and acceptance criteria.

• Assess equipment specifications and suitability for test method.

• Support equipment and test method improvements and update of test method related work instructions where required.

• Training of personnel on test method related work instructions and forms

• Liaise with multiple departments to ensure timely completion of validation activities.

• Review statistical data and generate reports.

• Problem solve validation issues.

• Review and implement international test standards.

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What are we looking for?

• A Third level qualification in Science, Engineering or another relevant discipline.

• A minimum of two years’ experience in equipment Qualification and Test Method Validation.

• A minimum of two years’ experience in a regulated environment.

• Excellent communication skills, written and oral, with the ability to explain technical concepts concisely.

• A strong team player who works well with colleagues collaboratively.

• Proven track record of working well in cross-functional teams to achieve collective goals.

• Always displays excellent attention and takes a data driven approach to decision making.

• Comfortable analyzing various data sets effectively and efficiently.

• Ability to consistently meet deadlines in a dynamic professional environment.

• Strong technical writing skills and experience.

• 6 Sigma and Minitab experience is a distinct advantage.
  
  Interested in this role?

Apply for this job now by sending in a Word version of your CV or get in touch with Oliver at oliver@matrixrecruitment.ie

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and permission. Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position.

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