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.
THE ROLE: 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 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