Industrialization and Manufacturing Lead
vor 3 Monaten
We have the ambition to grow our team with a proactive approach to excellence and diversity, adding more passion and know-how with every individual we bring on board. To build a highly performant team and deliver the best possible solution to our customers, we are currently looking for an;
**INDUSTRIALIZATION AND MANUFACTURING LEAD (F/M, 100%)**
Location: Biopole, Epalinges, Switzerland
Start Date: 01 January 2025
You want to work in a fast-paced, mission-driven start-up environment? You have a passion for innovation, want to make a significant contribution to an ambitious project and be rewarded with opportunities? You are flexible and dedicated, ready to tackle challenges and broaden your skill set? This role is for you
**Position Summary**
To support Limula with the production of a solution for automated cell therapy manufacturing that includes hardware, single-use consumables and software products, you will contribute to the transition of new products from development to full-scale manufacturing, ensuring that Limula solutions are produced safely, efficiently, cost-effectively, and with the highest quality standards.
This role reports to the Head of Operations and will involve close collaboration with cross-functional teams, including Solutions, Engineering, Quality Assurance, Sales&Marketing to optimize manufacturing processes and support continuous improvement initiatives. It involves hands-on manufacturing and assembly of components and devices, and over time, to build a manufacturing team to execute on the following responsibilities:
- **Product Industrialization**:Contribute to the industrialization of new Limula products, including the development, implementation, and optimization of manufacturing processes to ensure the transition from prototype to final product.
- **Manufacturing Process Design and Optimization**:Design, develop, and optimize manufacturing processes and equipment to improve efficiency, reduce costs, and maintain quality standards. Implement Lean Manufacturing and Six Sigma methodologies to drive continuous improvement when necessary.
- **Tooling and Equipment**:Ensure that production equipment and tooling are capable of meeting production and quality requirements. Responsible for maintenance and calibration.
- **Manufacturing and Assembly**: Be responsible of the manufacturing and assembly of components and devices. Ensure that all manufacturing and assembly activities are performed according to established procedures and meet quality standards.
- **Documentation**:Develop and maintain manufacturing process documentation, including process failure mode and effect analysis (pFMEA), process validation, work instructions, standard operating procedures (SOPs), and process flow diagrams. Ensure all documentation complies with regulatory requirements and internal quality standards. Responsible to create and maintain the technical file documentation related to Industrialization and Manufacturing activities (DMR).
- **Supplier Interaction**:Work with suppliers to ensure components and materials meet specifications and quality standards. Participate in supplier audits and assessments if needed.
- **Regulatory Compliance**: Collaborate with the QARA department to ensure that manufacturing processes comply with relevant regulatory standards, such as ISO 13485, FDA 21 CFR Part 820, and other applicable regulations.
- **Cross-functional Collaboration**:Collaborate with other departments to ensure the manufacturability of new products. Provide technical support during the design phase to ensure design for manufacturability
- **Training and Support**:Provide training and technical support to production staff on new processes and equipment. Develop training materials and conduct training sessions as required.
**Requirements**:
- Degree in engineering or similar domain.
- At least 5 years of relevant experience in manufacturing and industrialization activities.
- Experience in a start-up company would be a plus.
- Ideally an expert in production processes in a highly regulated environment.
- Ideally, experience in working within life science ISO 9001 and ISO13485 certified companies.
- Creative, pro-active, self-motivated, flexible and ready to assume a wide variety of tasks.
- Problem-solving skills, solution-oriented mentality.
- Strong interpersonal and communication skills.
- Working proficiency in written and spoken English. French and/or German would be a plus.
- Willing and able to work full time, on-site at Biopôle, Lausanne, Switzerland.
**Benefits**
**Limula offers**
- Company mission that aims to impact the lives of patients with life threatening conditions.
- Innovative and multidisciplinary project, at the interface between engineering and biology.
- An opportunity to work in the Cell & Gene Therapy industry, one of the most exciting fast growing medical fields.
- Fast-paced, highly stimulating environment with a collaborative atmosphere.
- Unique opportunity to join a
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