Senior Validation Engineer
Longford and Dublin

Contract
Our esteemed Medical Device client is seeking a Senior Validation Engineer to lead and oversee the validation activities for an equipment transfer project between their Midlands and Dublin based sites. This is a critical role ensuring compliance, efficiency, and seamless integration in a highly regulated environment.


Key Responsibilities:
  • Lead validation activities related to the transfer, installation, and qualification of manufacturing equipment between sites.
  • Develop, review, and execute validation protocols (IQ, OQ, PQ) in compliance with regulatory standards (ISO 13485, FDA CFR Part 820).
  • Collaborate with cross-functional teams, including Engineering, QA, and Manufacturing, to ensure timely and compliant execution of validation tasks.
  • Troubleshoot and resolve validation challenges, ensuring minimal disruption to project timelines.
  • Maintain comprehensive documentation for all validation activities, including deviations, CAPAs, and final reports.
  • Support risk assessments and gap analyses related to equipment and process transfer.
  • Provide expertise on equipment functionality and compliance standards throughout the project lifecycle.


Requirements:
  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Minimum of 5 years of experience in validation within the Medical Device or Pharmaceutical industry.
  • Expertise in equipment qualification, process validation, and technology transfer.
  • In-depth knowledge of regulatory requirements, including ISO 13485, FDA regulations, and GAMP 5.
  • Strong project management skills, with the ability to prioritise and manage multiple tasks.
  • Excellent problem-solving and communication skills.