Job Title: Senior Validation Engineer
The Senior Validation Engineer is a member of the validation team in the Quality department of Creganna Medical.
Reporting to the Calibration/Validation Lead, the person is responsible for documentation and execution of validation activities in accordance with validation policy and procedures. This position is based in our Galway facility.
TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.Job Responsibilities Ensure regulatory compliance with international validation requirements. Act as the plant contact person and coordinator for equipment, process and computer validation/test activities. Work with team and other departments across the plant to ensure adherence to project schedules. Ensure procedures are kept up to date and maintained to the relevant standards and to industry best practice. Ensure best validation and test practices are employed by all departments across the company to maximize effectiveness and minimize non-value-adding work. Supervise Validation Engineer. Motivate individual to achieve results and assist staff in attaining performance/training objectives and career goals. Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems. Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team. Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained. Ensure validation documents are up-to-date (primarily project MVPs and key inputs). Manage the execution of the product/process validation as per the MVP and project plan. Work directly with customer validation representatives to define inputs and requirements to the MVP. Ensure all results and data are correct and follow-up on any gaps or discrepancies. Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment. Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions. What your background should look like:
QualificationsLevel 8 degree in Science/Engineering. 5+ years’ experience in a similar role within the Medical Devices or related Healthcare industry.
Key RequirementsStrong knowledge of ISO and FDA quality requirements. Good understanding of validation concepts and documentation. Strong communication skills, including ability to advise and influence. Excellent attention to detail and report-writing ability Proven ability to work on own initiative. Highly organized with strong ability to prioritize tasks. Good working knowledge and experience of statistical analysis methods is required.
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