CSV Engineer

• Integrally involved in the validation of all new computerised equipment, and control systems onsite.
• Generates validation documentation (protocols/reports) and helps 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. 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 plans.
• Review and approval of site change controls.
• Ensure compliance to cGMP at all times.

• 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 and 2-3 years' experience in validation environment.
• Project management experience.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Full understanding of relevant quality and compliance regulations.
• Good knowledge of quality management systems.

Tandem Project Management