Computer Systems Validation Engineer | Cork based | Computer software validation protocols | Contact Aideen: P: 021-4911061 E: aideen.kehoe@collinsmcnicholas.ie
The Role:
• 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.
Skills:
• Degree in Engineering or computing discipline or other 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.
Desirable:
• Experience with vendor equipment builds, process automation, machine vision systems and medical products.
• Experience working in a cGMP/FDA regulated environment.
• Knowledge of latest regulatory/industry standard approaches to Data Integrity.
For a confidential discussion and more information on the role, please contact Aideen Kehoe on 021-4911061 or email aideen.kehoe@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 at www.collinsmcnicholas.ie.
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