Immediate Job Opportunity

CSV Engineers to provide support to the company’s regional projects group now sought for a well-established business who are known for their high tech IT integration and regulatory compliance for global End Users, OEM’s and technology providers. 

Job Overview: Reporting to the Senior Validation Engineer, you will have experience in:

·         Defining test strategy

·         Designing and developing test cases from software requirements, architecture designs, and code of complex software systems.

You will possess the technical ability to understand the mechanical, electrical and software elements of various control systems.

Duties will include:

•       Participate in the development and review of software requirements.

•       Develop and review software validation plans, test protocols, test data and test reports

•       Execute test cases per protocol and document the results.

•       Work closely with the Software Engineering Team to ensure implementation and application of software validation principles throughout the development process.

•       Contribute to the preparation and review of the Validation Master Plan

•       Manage the preparation, review and issuing of software validation and equipment validation protocols and reports

•       Generate validation documentation including risk assessments, traceability matrices, and validation reports.

•       Review and approve specifications associated with computerised systems, equipment, processes and products.

•       Establish, implement and direct validation and revalidation activities.

•       Work directly with a cross functional team to define inputs and requirements to the Validation Master Plan.

•       Review and manage change control forms for Validation/Compliance implications.

•       Update existing quality documentation related to validation activities.

•       Identify training requirements in support of validation.

•       Conduct functional and software risk assessments.

The ideal CSV Engineers will be degree qualified with a minimum of 3 years’ experience in software engineering. Software validation and equipment validation experience within a regulated industry is essential. If you have knowledge of FDA 21 CFR, IEC 62304, GXP or GAMP5 please call Sarah Clarke on 01902 212 000 or 07519 122 547. Alternatively, email a copy of your current CV to sarah.clarke@automationexperts.co.uk quoting the above reference number. 

Should you have solid control systems engineering experience with some knowledge of validation and would be keen to develop further into this field, we are also interested to hear from you.

Roles are available in Limerick and Dublin