Direct message the job poster from Synergy Recruitment Partners
Senior Recruitment Consultant Contact: Aidan@synergyrecruitment.ie
Opportunity for a Senior Validation Engineer at manufacturing plant based in South Dublin in a critical leadership role driving standards, productivity, quality and continuous improvement.
The successful candidate will be responsible for overseeing and managing the validation and Advanced Product Quality Planning (APQP) lifecycle. 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.
* Produce and maintain appropriate and comprehensive validation policy and procedures.
* Ensure execution of allocated validations according to the plant Validation Master Plan.
* Write and implement validation system documentation as required.
* Ensure the review and approval of validation lifecycle documentation.
* As a member of the Quality group, ensure successful validation of all manufacturing processes.
* 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.
* Draft and Approve protocols and reports as required.
* Execution of IQ, Process Development, OQ and PQ on new/revised processes as required.
* Create and control PFMEA and control plans throughout product life cycle.
* Participate in regulatory audits and inspections.
Experience and Education
* BSc / BEng or a similar relevant technical degree.
* A minimum of 5 years high volume engineering experience in Medical Devices.
* A minimum of 3 years validation experience.
* Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes.
If interested in learning more please send an updated CV to Kyle@synergyrecruitment.ie
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Engineering and Manufacturing
Industries
* Medical Equipment Manufacturing
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