- 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.
- 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.
- 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 firstname.lastname@example.org
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