Social network you want to login/join with:
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
* Integrally involved in the validation of all new equipment, processes and control systems
* Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, laboratory equipment, and computerised systems.
* Participates in the change control process advising on validation issues, as appropriate
* Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
* Ensures projects are managed in compliance with all required legal requirements (Health & Safety, cGMP, construction, environmental etc ).
* 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.
* Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing and sterilisation.
* Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
* Review and approval of site change controls
JOB REQUIREMENTS
* Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
* 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
* Experience in qualification of laboratory equipment
* Knowledge of requirements for of GAMP, ISPE Baseline guide is desirable
* Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines is desirable.
#J-18808-Ljbffr