Process Validation Engineer

Galway
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 new medical 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.