Site Validation Specialist

4 days ago

Sligo, Sligo, Ireland beBeeValidation Full time €60,000 - €80,000
Job Overview

A validation engineer is required to develop and execute site validation strategies that meet stringent industry standards.

Key Responsibilities
  • Validate and assure compliance of site equipment, utilities, processes, and software with policies, FDA, European cGMP, and GAMP standards.
  • Develop and implement site validation master plans and project validation plans.
  • Generate validation protocols and final reports that meet cGMP standards.
  • Manage validation, exception event, and change control processes to ensure seamless operations.
  • Collaborate with the team to maintain cGMP compliance of production areas.
Desirable Experience
  • Engineering or scientific degree.
  • Extensive validation/quality experience in medical device plastics processing, moulding, or assembly operations.
  • Strong communication, presentation, and troubleshooting skills.
  • Effective interpersonal and organisational skills.

The ideal candidate will have a strong background in engineering and quality assurance, with excellent communication and teamwork skills. They must be able to work effectively in a collaborative environment to drive business success.

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