Equipment Specialist

2 weeks ago

Galway, Galway, Ireland beBeeEngineering Full time €60,000 - €80,000

We are seeking a highly skilled and dynamic engineer to fill a key role in our organization.

Job Responsibilities
  • Develop and execute comprehensive documentation for equipment and systems, encompassing functional specifications, software design specifications, calibration specifications, and related documentation.
  • Collaborate with cross-functional teams to create and implement validation protocols, including IQ/OQ/PQ, Test Method Validations, and Test Method development.
  • Maintain control over software assets and ensure adherence to validation procedure guidelines.
  • Ensure Quality Policy and Quality system procedures are upheld by promptly reporting noncompliance issues to management.
  • Work collaboratively with the Quality department to guarantee all validations align with industry standards.
  • Cultivate effective relationships with stakeholders through collaboration on project deliverables.
  • Monitor project schedules and scope changes to ensure timely delivery of project requirements.
Requirements
  • A Bachelor's degree in Life Science, Engineering, or a closely related field is mandatory.
  • Previous experience in Research & Development within the medical device industry is desirable.
  • A minimum of 3-4 years of Equipment and CSV experience within the medical device industry is required.
  • Excellent communication, team, and organizational skills are essential.
  • The ability to work independently and proactively manage assigned tasks to meet deadlines is necessary.
  • The capacity to establish and maintain positive working relationships with colleagues is crucial.

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