Job DescriptionA Computer Systems Validation Engineer is required by CareerWise Recruitment for our Waterford based Pharmaceutical client.
This is a 12-month contract.
If you have experience with CSV Validation then this is the position for you !!
Initially 100% onsite; after the first few months, up to two days per week remote working may be possible (on of the working days needs to be Monday or Friday) Role of this positionIntegrally involved in the validation of all new computerised equipment, and control systems.Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems.Participates in the change control process advising on CSV issues, as appropriateHands on role in the development and execution of DQ, IQ, OQ and PQ activities.Ensures projects are managed in compliance with all required Sanofi and 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 lyophilization, aseptic processing and sterilisation.Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.Maintain validation documentation through the Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans Generate/review/approve execution of the validation/revalidation plan.Review and approval of site change controls Ensure compliance to cGMP at all timesInitially 100% onsite; after the first few months, up to two days per week remote working may be possible (on of the working days needs to be Monday or Friday)
JOB REQUIREMENTS
Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec3-5 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