Job Title
Software Validation Engineer

Location: Sligo
Contractor Opportunity

As a Software Validation Engineer you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure that validation work is being carried out as per company validation policies & procedures.


  • Contributing to the preparation and review of the Validation Master Plan
  • Generating validation protocols and reports in accordance with cGMP and customer requirements
  • Execution of protocols for equipment, process, utilities, methods and computerised systems
  • Managing the execution of the equipment/software/process validation as per the MVP and project plan
  • Provide guidance to Junior validation engineers
  • Conducting internal projects against internal validation policies and procedures
  • Managing the preparation, review and issuing of validation protocols and reports in accordance with cGMP and customer requirements
  • Generating validation documentation including risk assessments, traceability matrices, and validation reports
  • Reviewing and approving specifications associated with Equipment, Processes, Products and Computerised Systems
  • 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 Risk Assessments
  • Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical devices
  • 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


  • Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline
  • Over 3-5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry
  • Experience with OSI PI systems is required – development level experience is not a requirement but system knowledge is required
  • SAP system experience is highly advantageous
  • 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
  • Excellent communication skills, including ability to advise and influence
  • Excellent attention to detail
  • Excellent understanding of validation concepts and documentation

Why Choose This Role & SL Controls

  • An excellent compensation package which rewards high performers
  • The opportunity to work clients who are global leaders in their field
  • A supportive environment committed to employee development and wellness
  • The opportunity to work with, help develop and improve upon industry leading technology solutions
  • A collaborative and open culture where you are valued and can contribute to company initiatives and growth

About SL Controls

SL Controls are experts in the area of Equipment System Integration and System Support. We specialise in assisting our customers, including many of the world’s top multinational companies in the medical device and pharmaceutical sectors, achieve their Six Sigma and OEE targets. Over the past 18 years we have grown our business from a Sligo based enterprise into an international business with additional offices in Galway, Limerick, Leinster and Florida USA. We pride ourselves on our expertise in industrial IT integration and regulatory compliance in support of global end users, OEM’s and Technology providers.

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