As a Reagent Manufacturing Engineer you'll be responsible to solve medium complexity problems and recommend innovative solutions. You will provide manufacturing technology and robust solutions aimed at commercializing new products and continuously improving production processes.
Working cross-functionally with Technical Development teams across the company, as well as with Quality Control, Clinical Operations, and Quality Assurance, you will resolve problems encountered on the production floor, and will apply your engineering knowledge and creativity to implement adaptations and modifications to production and to quality systems.
You will work with cross functional teams that explore, develop, optimize, test, and implement robust, scalable solutions for Visby Medical with attention to understanding business and user requirements and improving efficiency, throughput, and quality.
The successful candidate will apply scientific methods and engineering skills to improve the scalability of Visby’s reagent Manufacturing Operations with assistance from Technical Development teams and Operations management.
Essential Duties and Responsibilities:
- As a point person in leading process and equipment transfer from R&D into Manufacturing Operations.
- Provide user requirements to project teams to ensure manufacturability of processes/methods.
- Develop, refine and release Work Instruction or Work Forms from Development team into Manufacturing via Change Control.
- Provide sustaining support, including troubleshooting, process improvement, and new equipment specifications.
- Support production by training manufacturing associates and quality control technicians, creating and maintaining product and process documentation, and implementing process improvements that increase yield, efficiency, and/or throughput.
- Lead/participate in non-conformance investigation and CAPA closure Execute root cause analyses and recommend vetted solutions.
- Maintain manufacturing processes in validated state.
- Process Optimization/Standardization Optimize production processes by designing fixtures, acquiring off-the-shelf tooling and equipment, and implementing new fixturing on the production line.
- Lead 5S and continuous improvement projects.
- Coordinate with suppliers and other external resources needed in developing and implementing process improvement plans.
- Must be collaborative and able to effectively participate in cross functional teams working in a variety of projects.
- You're an engineer with a proven track record of production floor support.
- You're eager to participate in troubleshooting process problems and developing solutions to resolve/mitigate risks.
- An interdisciplinary background in molecular biology, lab automation is desirable.
- The ideal candidate will have prior, demonstrated experience developing, testing, implementing, trouble shooting and supporting kit assembly, liquid dispensing, formulation and automation using a requirements-driven approach in a molecular biology-based laboratory setting.
- You will also apply engineering, molecular biology, and/or biochemistry knowledge to troubleshoot manufacturing issues.
- A BS degree in engineering or science, preferably in molecular biology, genetics or biochemistry, bioengineering, mechanical/chemical engineering or a closely-related discipline and 2-4 years of related experience. A MS degree with 1-3 years related experience.
- Experience in streamlining workflows and developing robust manufacturing processes.
- Hands-on experience with operating and programming liquid handling robotics platforms.
- Experience with freeze drying/lyophilization is a plus.
- Experience working within regulated environments (FDA, IVD, LDT, ISO, etc.) is preferred.
- Strong communication and collaborative skills, working with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.
- Experience with statistical data analysis, monitoring data quality, and troubleshooting technical problems is a plus.