Computer Systems Validation Engineer | Cork-based | Computer software validation protocols | Contact Aideen: P: 021-4911061 E: firstname.lastname@example.org
- Preparation and execution of computer software validation protocols, test scripts and reports.
- Evaluation of changes to validated/qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
- Lead and participate in risk management activities e.g. FMEAs.
- Investigation of software-related deviations and non-conformances as part of the quality team.
- Review of all software related GMP critical documents, e.g. Requirement documents, software validation protocols, Change Controls.
- Participate in software corrective action process e.g. perform root cause investigations and develop CAPA plans.
- Review of pre-delivery or vendor-supplied information with regards to suitability to proceed with validation activities.
- Travel to vendor locations for project reviews will be required.
- Provide technical expertise in the validation of new technologies to ensure they meet the Safety, Quality and Operational requirements.
- Degree in Engineering or computing discipline or another similar technology degree.
- 3-5 years’ experience in a similar role within engineering or computer system validations.
- Experience in high-volume low-cost manufacturing systems.
- Knowledge of software development life cycle methodologies
- Knowledge of statistical analysis and machine vision fundamentals would be a plus.
- Participation in team-based project work with cross-functional team members.
- Ability to communicate Validation concepts/strategies to project teams.
- Be a self-starter and be adaptable to a fast-paced working environment.
- Be able to integrate into current groups and interact well with people.
- Experience with vendor equipment builds, process automation, machine vision systems and medical products.
- Experience working in a cGMP/FDA regulated environment.
- Knowledge of the latest regulatory/industry-standard approaches to Data Integrity.
For a confidential discussion and more information on the role, please contact Aideen Kehoe.