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Urgent! Validation Engineer Job Opening In Cork – Now Hiring CareerWise Recruitment

Validation Engineer



Job description

Job Description

A Validation Engineer is required by CareerWise Recruitment for our Waterford based pharmaceutical client.

If you are experience in aseptic processing, lyophilisation, sterilisation and depyrogenation.

This is a 12 month contract.

Role of this position

  • Designing, executing and reporting on PV/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 for aseptic processing, lyophilisation, sterilisation and depyrogenation
  • Maintaining validation documentation through the validation lifecycle
  • Participation in external regulatory inspections and supporting Support Site Change Control process
  • Capable of troubleshooting validation issues associated with projects, process development etc.
  • Maintaining validation documentation through the validation lifecycle

  • JOB REQUIREMENTS


  • Degree in Science (Chemistry, Micro.

    or Pharmacy preferred) or Engineering Chemical/Mech/Elec
  • Previous validation/product development experience would be highly advantageous for the role.
  • Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
  • Knowledge of requirements for of 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

  • Required Skill Profession

    Engineers



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