Description
Responsible for the day-to-day authoring and execution of Computerised Systems Validation activities on a specific site based project. Work with the QA Validation and Automation Teams to ensure validation deliverables are completed per schedule.The CSV Engineer will need to be proactive and not a manager! They’ll be looking for someone with a minimum of 5 years CSV background within Pharmaceuticals and experience of working within projects. My client has implemented a new SCADA based equipment on a new sterile filling line project and need someone to come in to write full CSV lifecycle documentation!
Key Skills and Experience:
Extensive CSV Engineering experience
Experience of implementing new SCADA based equipment
Pharmaceutical Sterile Manufacturing experience
Strong understanding of GAMP5
Experience in the assessment of computerized equipment for 21 CFR Part 11 / Annex 11 compliance
Thorough understanding of CSV and QA roles, responsibilities and interactions is required