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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