Cache of job #13864139

Job Title

Senior CSV Engineer - Sligo


Keltia Ireland Ltd


Leitrim, Sligo


Keltia Ireland Ltd is a technical support services company providing engineering CAD design, CAD training and a broad range of technical recruiting services to customers in the Aerospace, Automotive, Medical Device and other engineering industries on a permanent and contractual basis. We opened our office in Ireland in 2012 and we have an Irish owned sister company in the US, Keltia Design, Inc. that has been in business for over 17 years. Our Client in the West of Ireland region is a leading provider of innovative and advanced electronic components and solutions for a wild variety of industries, including the automotive, aerospace, medical and consumer products industries. They are currently seeking a Senior CSV Engineer for a permanent position. This promises to be an exciting opportunity for a suitable candidate with the right experience. Responsibilities: Contributing to the preparation and review of the Validation Master Plan. Generation of all validation strategies and deliverables. Development and maintenance of internal validation policies and procedures based on best international standards and practices. Auditing of internal projects against internal validation policies and procedures. Managing the preparation, review and issuing of validation protocols and reports. Generating validation documentation including risk assessments, traceability matrices, and validation reports. Reviewing and approving specifications associated with Equipment, Processes, Products and Computerised Systems. Establishing, implementing and directing validation and revalidation activities. Working directly with a cross functional team to define inputs and requirements to the MVP. Reviewing and managing change control forms for Validation/Compliance implications. Conducting routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise. Updating existing quality documentation related to validation activities. Generating Standard Operating Procedures (SOP’s. Identifying training requirements in support of validation. Conducting Risk Assessments. Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical device. Execute test cases per protocol and document the results. Participate in the development and review of software requirements. Contribute to the design and implementation of software validation processes on projects. Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process. Provide technical direction and hands-on assistance for testing projects. Reviewing vendor validation documentation. Co-ordinating the validation activities (including the vendors. Requirements: Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline. Over 5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry. Experience of GxP Computerised Systems. Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements. Familiar with the GAMP5 guidelines. Experience with serialization. Experience with Systech Technology. Excellent communication skills, including ability to advise and influence. Excellent attention to detail. Excellent understanding of validation concepts and documentation. Should be based within a commutable range or else willing to re-locate for 1 year period. Expected to be on site during the project with the exception of attendance at any FAT. . This job originally appeared on

Date Added

370 days ago