Jobs in Ireland

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.

• Performing and overseeing process and test method validation activities within the project.

• Execution of 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.

• Ensuring 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 trouble-shoot validation problems which may occur and determine solutions.

• Communication of validation results and progress to management.

• As required, prepares summaries of validation testing for regulatory submissions, and presents validations to regulatory agencies.

Qualifications & Experience:

• Bachelors 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 organisational, management and communication skills.

• Good interpersonal & communication skills essential.

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For a confidential discussion and more information on rates, please contact Davin Ferguson

davin.ferguson@collinsmcnicholas.ie

071 91 40251