Senior Validation Engineer

3 weeks ago


Galway, Galway, Ireland Cure Talent Full time

This range is provided by Cure Talent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

Cure Talent is thrilled to partner with an innovative company at the forefront of developing cutting-edge healthcare technology. This is a unique opportunity to contribute to a pioneering solution that improves patient outcomes and meets the highest regulatory standards.

As the new Senior Validation Engineer, you will be responsible for leading and executing validation activities across processes, test methods, and manufacturing operations. You will ensure that all validation procedures comply with regulatory and industry standards, while also identifying and resolving any validation-related challenges. Your expertise will be critical in supporting product development, ensuring manufacturing readiness, and contributing to regulatory submissions.

Key Responsibilities:

  1. Develop, review, and approve validation documentation, including protocols, records, and reports.
  2. Execute process and test method validation activities in collaboration with cross-functional teams.
  3. Ensure all validation work aligns with Good Manufacturing Practices and regulatory requirements.
  4. Investigate and resolve validation challenges, implementing effective solutions.
  5. Provide validation summaries for regulatory submissions and liaise with regulatory agencies when required.

What We're Looking For:

  1. Degree in Engineering, Technology, or a Scientific Discipline.
  2. 5+ years' experience in validation within the medical device or pharmaceutical industry.
  3. Strong knowledge of ISO 13485 and 21 CFR 820 compliance.
  4. Proven experience in process validation and test method validation.
  5. Excellent analytical, problem-solving, and communication skills.

Be part of an innovative team that is making a real difference in patient care and shaping the future of healthcare

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Engineering, Product Management, and Quality Assurance

Industries

Medical Equipment Manufacturing

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