Software Validation Engineer – Limerick | Collins McNicholas

Software Validation Engineer – Limerick

  • Reference: CJ43577
  • Job Type: Permanent
  • Location: Limerick, Limerick City, Munster
  • Category: Information Technology

Job Description

As the Software Validation Engineer you will provide software validation support to the company’s regional projects groups located in Dublin and Limerick.

Reporting to the Senior Validation Engineer, as the successful candidate 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.

 

Desired Skills and Experience

  • Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline
  • A minimum of 3 years of industry experience in software engineering
  • Software Validation and Equipment Validation experience in a regulated industry: FDA 21 CFR 820, the Quality System Regulation, ISO 13485, and IEC 62304
  • Experience of GxP Computerised Systems
  • Understanding of GAMP5 Guidelines
  • Understanding of validation concepts and documentation
  • Excellent communication skills, including ability to advise and influence at all levels within the company

 

Key Responsibilities

  • 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

 

 

For a confidential discussion and more information on the role, please contact Kaylie on      021 4911064 or email kaylie.obrien@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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Kaylie O'Brien

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