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.
For a confidential discussion and more information on rates, please contact Davin Ferguson
davin.ferguson@collinsmcnicholas.ie
071 91 40251