Job Title: Senior Validation Engineer

Location: Pottery Road, Dun Laoghaire, Dublin.

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

Company:
For nearly 100 years, my client have been accelerating the journey to better diabetes care. With the creation of the first insulin delivery device, they have delivered an innovation that moved the management and treatment of diabetes forward.

Overview:
In this role you will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle at our Dun Laoghaire site. In this pivotal role, you will be responsible for leading the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively. Additionally, you will drive continuous improvement initiatives to enhance processes and maintain the highest quality standards.

Responsibilities

• 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.
• Ensure execution of allocated validations according to the plant Validation Master Plan.
• Provide input, monitor and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews.
• Write and implement validation system documentation as required.
• Ensure the review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures
• Develop and maintain processes and procedures to ensure product and process transfers are achieved efficiently
• As a member of the Quality group, to liaise with Operations, planning and Engineering groups to ensure successful validation of all manufacturing processes.
• Plant SME for Process Validation Execution
• 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
  
  

• 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
• Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes
• Process development experience (DOE’s etc)
• Risk Analysis/Risk Management, FMEA’s, etc.
• Strong documentation skills
• Ability to work on own initiative and as part of a team.
• Strong interpersonal and communication skills.
• Process validation training and experience
• Strong technical and problem-solving skills.