We're searching for a Senior Validation Engineer who will oversee and manage the validation and Advanced Product Quality Planning (APQP) lifecycle at a site based in South Dublin.
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.
Plant SME for Process Validation Execution.
Manage the activities of a defined team of Validation Engineers, including training, coaching and managing day to day work.
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.
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.
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.
Process validation training and experience.
If you are interested in this role, please click the apply button or contact Nicole at or call .
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
Skills: APQA GMP DOE SME IQ OQ PQ