Engineering Manager

1 week ago

Dublin, Dublin City, Ireland beBeeValidation Full time €90,000 - €120,000
Job Title: Senior Validation Engineer

In this role, you will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle at our site. You will be responsible for leading the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively.

  • Be a team leader within the validation team for all technical and equipment validation projects in line with predetermined protocols and production requirements.
  • Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.
  • Develop a strategy to ensure that the validation approach satisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective and appropriate use of process development and DOE activities.
  • Produce and maintain appropriate and comprehensive validation policy and procedures.

Responsibilities:

  • Manage the activities of a defined team of Validation Engineers.
  • Management responsibilities to include day to day work allocation and prioritisation of work, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties.
  • Draft and Approve protocols and reports as required.
  • Execution of IQ, Process Development, OQ and PQ on new/revised processes as required.

Requirements:

  • BSc / BEng or a similar relevant technical degree.
  • A minimum of 5 years high volume engineering experience in a Medical Devices.
  • A minimum of 3 years validation experience.

Benefits: Competitive salary, Share options, Pension, Healthcare, Annual bonus + excellent opportunity to develop your experience and career.

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