System Validation Professional

1 day ago

Waterford, Waterford, Ireland beBeeValidation Full time €60,000 - €80,000

Job Overview:

The role of a Validation Specialist is to design, execute and report on process validation studies for equipment, systems and processes. The successful candidate will provide technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.

Responsibilities:

  • Designing, executing and reporting on process performance qualifications
  • Designing, executing and reporting on validation studies for equipment, systems and processes
  • Providing technical interpretation and guidance of current US FDA and EU validation requirements
  • Maintaining validation documentation through the validation lifecycle
  • Participation in external regulatory inspections and supporting
  • Support site change control processes
  • Capable of troubleshooting validation issues associated with projects, process development etc.

Requirements:

  • Degree in Science (Chemistry, Micro or Pharmacy preferred) or Engineering Chemical/Mech/Elec
  • Previous product development experience would be highly advantageous for the role
  • Knowledge of process validation regulations, current process validation industry practices, and experience of interpretation and application of guidelines and regulations
  • Knowledge of requirements for GAMP, ISPE Baseline guides
  • Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines
  • Full understanding of relevant quality and compliance regulations
  • Able to execute projects to plan
  • Good knowledge of quality management systems
  • Good communication skills at organisation, team and individual levels
  • Ability to use MS Project and SPC packages an advantage

About This Opportunity:

Career Wise Recruitment is a specialist recruitment agency operating out of multiple locations in Ireland serving the life sciences sector.

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