Supply Chain & Logistics JobsComputer Systems Validation Engineer

  • CJ50863
  • Permanent
  • Cork, Munster

Collins McNicholas

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 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.   

Desirable:

  • 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.

021-4911061

aideen.kehoe@collinsmcnicholas.ie

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