CSV Engineer Waterford

Job Overview


Excellent opportunity for an experienced CSV Engineer to join an expanding Healthcare company in Waterford. You will be joining a highly sought after company and working within a friendly and supportive team. Permanent position


Responsibilities

  • 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 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


Requirements

  • 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

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