Manufacturing Process Optimization Expert
7 giorni fa
Infrastructure & Logistics Specialist (Open)
The Opportunity
Tensive is a biomedical company that is developing an innovative scaffold aiming to improve breast cancer patients' quality of life, by offering a natural breast reconstruction.
We are looking for an Infrastructure & Logistics Specialist who will manage and optimize manufacturing processes to ensure compliance with GMP requirements, focusing on enhancing production efficiency and quality. This role involves conducting time studies, equipment validation, and collaborating with various departments to improve overall equipment effectiveness and operational performance.
The Role
This specialist will also contribute to the development and validation of production equipment and processes, ensuring adherence to international guidelines and regulatory standards. Responsibilities include collecting manufacturing process analytical data, developing process flow diagrams, and performing work measurements to analyze and improve existing processes.
An additional duty will be recommending and implementing modifications to equipment to improve productivity and efficiency. The specialist will coordinate activities to address equipment performance issues, develop regular maintenance tasks, and follow best practices around Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to develop safe and quality processes.
Collaboration in developing engineering documentation to define technical and functional specifications of existing and new equipment is another key responsibility. Furthermore, the specialist will participate in the development and validation of equipment in compliance with internal guidelines.
The position requires collaboration with other departments and external contractors in equipment validation activities and resolving product and process non-conformities. Additionally, the specialist must ensure the implementation of the Company's Quality Management System across all activities, focusing on equipment validation and process improvements.
Requirements
To be successful in this role, you should have:
- A MSc in Scientific disciplines or equivalent qualification.
- 2+ years of experience in a manufacturing environment.
- Practical experience in the use and maintenance of production and laboratory tools for chemical and biological activities.
- Experience with Risk Analysis methods (e.g., FMEA).
- Knowledge of quantitative and qualitative approaches, as well as organizational, operational, and technical aspects of business processes.
- Good computer skills.
- Precision, reliability, ability to work both independently and in a team.
The estimated salary for this position is between $90,000 and $110,000 per annum, depending on location and experience. Please note that this is a competitive salary range and not specific to Tensive.
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