A Computer Systems Validation Engineer is required by CareerWise Recruitment for our Waterford based Pharmaceutical client. This is a 12-month contractor position with an hourly rate. The working arrangement is initially 100% onsite, with the possibility of up to two days per week remote working after the first few months, with one of the working days being Monday or Friday.THE ROLE:Integrally 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 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 Sanofi and legal requirements (Health & Safety, cGMP, construction, environmental, etc.).Designs, implements, and executes validation studies for manufacturing and control equipment, with additional responsibilities for critical systems and facilities, as well as validation studies to satisfy regulatory compliance.Provides technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing, and sterilization.Ensures that the validation status of equipment and systems are in compliance with cGMP at all times.Maintains validation documentation through the approval and implementation of changes to relevant systems and assists in generating validation/revalidation plans.Generates, reviews, and approves the execution of the validation/revalidation plan.Reviews and approves site change controls.REQUIREMENTS:Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical, Mechanical, or Electrical).3-5 years of experience working in a Healthcare manufacturing environment, ideally part of which would be in the pharmaceutical sector.2-3 years of experience in a validation environment.EQUAL EMPLOYMENT OPPORTUNITY: CareerWise Recruitment is an equal opportunities employer.
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