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Senior Operational Excellence Manager
1 month ago
Our client is a rapidly growing, leading biologics company located in the greater Miami area and is in immediate need of a Senior Operational Excellence Consultant for a 6-month project. This is an onsite engagement and has a strong likelihood of extension based on performance.
The Senior Operational Excellence Consultant will be critical in developing, tools and methodologies to drive operational excellence, process improvement related to manufacturing, raw materials acquisition process.
Essential responsibilities:
- Provide guidance and direction to drive the implementation of process improvement strategies to enhance process efficiency and quality. Lead / support process transformation improvement strategy.
- Collaborate on development and execution of transformation improvement strategy.
- Conduct in depth analysis of existing processes to identify inefficiencies, and areas for improvement.
- Design / implement process and process flow improvements to increase productivity, maintain / improve product quality.
- Utilize methodologies, approaches to drive continuous improvement efforts.
- Participate in team problem-solving activities to drive results, enact needed changes
- Experience working with FDA Quality Systems Regulations and ISO Quality Systems
- Collaborate on strategy deployment and execution.
- Support new process introduction and ramp-up plans. Apply best practices to facilitate success.
- Collaborate with regulatory, engineering, QA/QC teams to improve processes, and optimize performance.
Requirements
- Demonstrate a strong ability to communicate concepts, ideas, and knowledge effectively to other individuals and teams both verbally and in writing.
- 8-10 years of applicable OPEX experience in pharma, biotech, medical device
- Self-motivated with the ability to provide and receive constructive feedback.
- Mentor less experienced colleagues
- Have a strong understanding of technology, technology systems, platforms, tools.
- knowledge of Environmental, Health & Safety practices
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