Junior Validation Engineer – Limerick | Collins McNicholas

Junior Validation Engineer – Limerick

  • Reference: CJ43615
  • Job Type: Permanent
  • Location: Limerick
  • Category: Engineering, Technical & Manufacturing

Description: As the Junior Validation Engineer you will be primarily responsible for documentation and execution of validation activities in accordance with validation plans and procedures, for a specific project.

 

Responsibilities:

  • Generating validation protocols and reports in accordance with cGMP and customer requirements
  • Assisting in the execution of protocols for equipment, process, utilities, methods and computerised systems.
  • Ensuring that all results and data are correct and following up and closing out any gaps or discrepancies. 
  • Troubleshooting validation issues associated with the validation project and provide feedback to the equipment/software/process design team.
  • Ensuring consistency on validation/qualification approach across systems and projects.
  • Reviewing and approving changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
  • Ensuring validation documents across multiple client projects are up-to-date 
  • Managing the execution of the equipment/software/process validation as per the MVP and project plan.
  • Working directly with a cross functional team to define inputs and requirements to the MVP.
  • Liaising with a cross functional team to ensure that equipment/software/process validation requirements are maintained
  • Providing guidance and direction in the preparation and execution of validation activities
  • Maintaining validation procedures and ensuring templates are up to date, focusing on continuous improvement.

 

Requirements:

  • Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline.
  • Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.
  • 1 – 2 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry  
  • Good understanding of validation concepts and documentation.
  • Strong communication skills.
  • Proven ability to work on own initiative.
  • Excellent attention to detail.
  • Highly organized with strong ability to prioritize tasks.
  • A general knowledge and experience of statistical analysis methods is an advantage.
  • Proven track record of excellent time keeping & attendance is essential.

 

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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  • Kaylie O'Brien
  • Recruitment Consultant
  • 021 4911064
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