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Validation Specialist

3 weeks ago

Athlone, County Westmeath, Ireland Signature Orthopaedics Full time
Job Summary:

We are seeking a skilled Validation Engineer to ensure manufacturing processes and equipment meet regulatory and quality standards for the medical devices industry.

This role involves hands-on validation activities, as well as the development of comprehensive validation protocols, work instructions, and standard operating procedures (SOPs).

  1. Develop, execute, and maintain validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
  2. Create and update work instructions, SOPs, and other documentation to ensure compliance with regulatory requirements.
  3. Conduct hands-on validation activities, including equipment qualification and process validation.
  4. Collaborate with cross-functional teams, including engineering, quality, and production, to support validation initiatives.
  5. Analyze validation test results and prepare detailed reports with recommendations for improvements.
  6. Ensure compliance with relevant regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR).
  7. Identify potential risks and develop mitigation strategies in validation processes.
  8. Support audits and inspections by regulatory bodies and customers.
  9. Continuously seek improvements in validation processes and documentation to enhance efficiency and compliance.
Qualifications:
  1. Bachelor's degree in engineering, Science, or a related field.
  2. Minimum of 3-5 years of experience in validation within the medical devices industry.
  3. Strong expertise in writing validation protocols, work instructions, and SOPs.
  4. Hands-on experience with equipment qualification and process validation.
  5. Excellent knowledge of regulatory requirements for medical devices (ISO 13485, FDA, EU MDR).
  6. Strong problem-solving skills and attention to detail.
  7. Excellent communication and technical writing skills.
  8. Ability to work independently and as part of a team in a fast-paced environment.