Validation Engineer

1 week ago

Waterford, Waterford, Ireland TN Ireland Full time

A Validation Engineer is required by CareerWise Recruitment for our Waterford based Pharmaceutical client. This is a 12 month contracting position. If you have experience in Validation in an API environment then this is the position for you

Role of this position
  1. Integrally involved in the validation of all new equipment, processes and control systems.
  2. Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, laboratory equipment, and computerised systems.
  3. Participates in the change control process advising on validation issues, as appropriate.
  4. Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
  5. Ensures projects are managed in compliance with all required legal requirements (Health & Safety, cGMP, construction, environmental etc).
  6. Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
  7. Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing and sterilisation.
  8. Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
  9. Review and approval of site change controls.
Job Requirements
  1. Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
  2. 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  3. 2-3 years experience in validation environment.
  4. Experience in qualification of laboratory equipment.
  5. Knowledge of requirements for GAMP, ISPE Baseline guide is desirable.
  6. Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines is desirable.
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