CSV Validation Specialist

1 week ago

Waterford, Waterford, Ireland beBeeValidation Full time €53,000 - €73,000
Job Description

The CSV Engineer plays a pivotal role in ensuring ongoing validation compliance of computerized equipment and systems in sterile products manufacturing.

Key responsibilities include:

  • Integrally involved in the validation of all new computerized equipment, and control systems
  • Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerized equipment and systems
  • Participates in the change control process advising on CSV issues as appropriate
  • Ensures projects are managed in compliance with all required legal requirements
  • Designs implements and executes validation studies for manufacturing and control equipment
  • Provides technical assistance on current US FDA and EU validation requirements for lyophilization aseptic processing and sterilization
  • Ensures that the validation status of equipment and systems are in compliance with cGMP at all times
  • Approves and implements changes to relevant systems and assists in generating validation revalidation plans
  • Generates reviews and approves execution of the validation revalidation plans

Required Skills and Qualifications

  • Degree in Science Chemistry Microbiology or Pharmacy preferred
  • Post graduate studies as appropriate to augment primary degree
  • 3 5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector
  • 2 3 years experience in validation environment
  • Project management experience
  • Full understanding of relevant quality and compliance regulations
  • Able to execute projects to plan
  • Good knowledge of quality management systems
  • Effective facilitator
  • Good communication skills at organization team and individual levels
  • Understands KPI's for the site

Benefits

This role offers an exciting opportunity to work in a dynamic environment and contribute to the success of the company.

Others

Please note that this is a general job description and may not include all duties or requirements associated with the position.

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