Overview:
We are seeking an experienced Senior Validation Engineer to lead the validation and Advanced Product Quality Planning lifecycle at our Dun Laoghaire site. This pivotal role will involve overseeing and managing technical aspects of the validation lifecycle, ensuring design transfer processes are executed effectively, and driving continuous improvement initiatives to enhance processes and maintain the highest quality standards.
* Key Responsibilities:
* Technical Leadership: Lead the validation team in technical and equipment validation projects, ensuring compliance with predetermined protocols and production requirements.
* Validation Management: Ensure that the design, installation, and operation of Plant and Equipment have been validated in accordance with current regulatory requirements.
* Strategic Approach: 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.
* Policy and Procedures: Produce and maintain comprehensive validation policy and procedures.
* Master Plan Execution: Execute allocated validations according to the plant Validation Master Plan.
* Compliance Monitoring: Monitor and report compliance on the content of the Validation Master Plan in conjunction with primary teams and corresponding management reviews.
* Documentation: Write and implement validation system documentation as required.
* Review and Approval: Ensure review and approval of validation lifecycle documentation, written in accordance with company standards and procedures.
* Process Development: Develop and maintain processes and procedures to ensure product and process transfers are achieved efficiently.
* Tech Enablement: Liaise with Operations, planning, and Engineering groups to ensure successful validation of all manufacturing processes.
* SME Support: Provide subject matter expertise for Process Validation Execution.
* Team Management: Manage a defined team of Validation Engineers, including day-to-day work allocation, prioritization, performance, output quality review, coaching, training, internal communications, and general personnel assistance.
* Protocol and Report Drafting: Draft and approve protocols and reports as required.
* Process Execution: Execute IQ, Process Development, OQ, and PQ on new or revised processes as required.
* Requirements:
* Candidate Requirements:
* Education and Experience: BSc / BEng or a similar relevant technical degree, minimum 5 years high-volume engineering experience in Medical Devices, minimum 3 years validation experience.
* Skills and Knowledge: 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, 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.
Does this sound like your next career move? To apply, forward your application to the link provided or contact us on 087 0608656.