Senior Validation Engineer
Galway - on site
6 month contract
AMC1234


We are partnering with an early stage medical device company looking to expand the team to support it’s development and manufacturing activities with the recruitment of a Senior Validations Engineer (6 month contract).

The requirements of this role within the wider project are to cover the validation activities with respect to the testing and manufacture of a class 3 medical device.

The ideal candidate will have 5+ years experience in Medical Device manufacturing inclduing process anddesign and execution of process and test method validations.

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.

• 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.