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Sr. Validation Engineer

1 month ago

Galway, Galway, Ireland EPM Scientific - Phaidon International Full time
Senior Validations Engineer

The requirements of this role within the wider project are to cover the validation activities with respect to the testing and manufacture of the client's device.

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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