הנדסה

PROCESS ENGINEER VALIDATION

117061

תאריך עדכון

29/01/2020

תיאור המשרה

 
 
 
Key Responsibilities:
    • Cover all aspects of manufacturing and packaging activities required for production of clinical products for all phases and commercial products
    • Liaison with CMOs
    • Optimize resources to meet the production plans in the manufacturing unit operations at the CMO’s sites as well as manage the process optimization of laboratory scale formulation and scale-up of the pre-commercial and commercial products
    • Manage the design and implementation of changes to improve the quality, costs and efficiencies of the process, equipment and methods of manufacturing
    • Plan and manage the technical transfer including protocols, design, monitoring, science, data management, statistics (KPIs) and reporting
    • Develop control of robust processes, review existing processes and equipment and configuring manufacturing systems to develop best practices
    • Performance Process Qualification (PPQ) includes supervise CMOs operations, participate in pre-validation and validation related activities, prepare and/or review protocols and process reports
    • Manage the Continuous Process Verification (CPV) process for commercial products in accordance with cGMP requirements
    • Provide technical assistance to manufacturing and quality operations for process troubleshooting as well working with QA to resolve production issues
    • Plan and execute post approval manufacturing changes
 
Requirements:
    • 15+ years of process development and/or manufacturing experience focusing in oral solid dosages production. Lyophilization expertise will be an advantage
    • Experience with technical transfer from lab scale to GMP manufacturing and scaling up to large scale batches (commercial batches)
    • Experience with Process Validation methodologies including regulations, guidelines, setting strategy for validation and writing of protocol & reports
    • Familiar with analytical methods development and QC methods
    • Team player with the ability to work collaboratively with CMOs and other functional area staff
    • Efficient organizational skills, including the ability to manage multiple tasks and priorities effectively
    • Full knowledge of planning and monitoring tools (Gant chart for example)
    • Working knowledge and understanding of the cGMP requirements
    • Self-learning skills
    • English at mother tongue level – excellent interpersonal, verbal and written communication skills in English
 
 
Education:
    • B.Sc in Biotechnology/ Chemical/ Material/ Mechanical Engineering or similar, MBA preferred
 
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