Senior Validation Engineer - South Dublin

Senior Validation Engineer - South Dublin.

As Senior Validation Engineer you will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle. 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 pre-determined 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 it is 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
• Local use of Validation Toolkits
• Publish site specific progress reports as required.
• Create and control PFMEA and control plans throughout product life cycle.
• Participate in regulatory audits and inspections.
• To link with Post-Validation activities including closure of ACR and ECO (Change Control).
• Support site change control procedures.

Experience and Education requirements:
• BSc / BEng or a similar relevant technical degree
• A minimum of 5 years' high-volume engineering experience in medical device manufacturing.
• 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.