A Validation Engineer is required by CareerWise Recruitment for our Waterford based pharmaceutical client.
If you are experienced 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 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
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