Description
Our client, one of the op Global Pharmaceutical Leaders looking for a Validation Engineer with previous ‘hands-on’ experience in:• Participate in design of systems and equipment, initiate and implement change control activities, coordinate validation activities with other departments, execute validation studies.
• Demonstrated capability to lead projects. Reporting progress to middle management
• Plan resources and actions to minimise the time required for process development, process improvements and validations.
• Evaluate completed validation work, to initiate and prioritise work that needs to be carried out in cooperation with Production and Quality department
• Development of trial protocols, hypothesis testing, validation protocols, the execution of validation testing, and the development of related reports.
• Monitor progress of trials, testing and validation, and the review and approval of validation protocols and reports within the required time schedule.
• Provide leadership from within Tech Ops group to resolve process issues within Production
Management, the manufacturing of development and registration batches at small scale, up scaling and manufacturing of development batches at full production scale
• Experience in applying Critical Quality Attributes (CQA’s) and determination of Critical Process Parameters (CPP’s) for validation/routine production to obtain a robust manufacturing process
• Manage and participate in the definition of manufacturing processes for new products (with R&D lead) and subsequent acceptance of the most robust, compliant and efficient product/process for manufacturing
• Act as on-site Subject Matter Experts as Product Stewards or Site Representatives on products and processes throughout their life-cycle, by providing product maintenance during the manufacturing life-cycle by evaluating the performance of the process, and liaise with Subject Matter Experts (SME’s) within Tech Ops network
• Ensure that all facilities, equipment and processes are in the validated state
• Lead the client’s site in the determination of the appropriate standards to apply in validation.
• Keep up-to-date with current approaches to validation and ensure introduction of those appropriate
• Ensure successful knowledge transfer to production re appropriate process/equipment operation parameters.
• Set up and maintain appropriate systems for the review of process and equipment parameters/results on an ongoing basis, i.e. maintenance of the validated state, in conjunction with Quality and Manufacturing.
• Maintain files on the validated state of equipment and processes, process rationale and trend analysis.
• Act as the primary process technology owner for area of responsibility through PPA Principles lead in the monitoring of CPP's, CQA's and other critical incidents through appropriate processes.
To apply for this fantastic opportunity please send in your CV for review.