Technical Process Director

该职位来源于猎聘 Key Responsibilities:

• Drive process capability improvements. Defines critical process parameters through the TRA process and input into product/process control strategies, specifically tacit knowledge of the process, and detailed how to guide in the event of a deviation for use by the operations and support functions.
• Development and use of product/process control strategies for new and mature products, supporting successful new product introduction to site.
• Development and generation of GMP documentation to support new product and existing product changes (e.g., MMIs & Batch Documentation). Manage system recipe editing/verification as required.
• Ensures all work is always conducted following good scientific practice and Good Manufacturing Practice (where required). Ensures all work is conducted in accordance with written procedures (e.g. quality and safety), methods & batch documents.
• Produces or contributes to, departmental quality documentation (including SOP's, batch documentation, manufacturing protocols & reports, product specifications & development reports).
• Executes key technical activities including trials, RCAs and validation activities where applicable.
• Supports or leads technical process improvements projects to improve sustainability, process capability, batch cycle-time reduction, reduce costs or improve value to support value engineering and/or safety of manufacturing processes.
• Monitors product/process performance (PPLM governance), evaluates and drives actions for continuous improvement of product families and CQA’s, working with other site functions.
• Enables successful technical transfer to the site.
• Provide technical expertise to challenges and issues on established products. Solve project-related problems by leveraging your scientific expertise and problem-solving skills.
• Own the making equipment testing/ FAT success criteria.
• Own the startup of the making system, documentation and hand over to operation. Requirements:
• BS degree or equivalent experience
• Chemical or Mechanical Engineering.
• Strong technical knowledge and experience in consumer products, with excellent understanding of Drug and Food GMPs as relevant to Consumer Healthcare as well as familiar global regularity requirements.
• Process analysis tools such as RCA and their application to support process understanding.
• Significant problem-solving skills with a proven record of resolving major issues at their root cause through working with engineering, technical and operations.
• At least 6 month industry experience.