Sr. Process Engineer
33 Technology Irvine, CA 92618
The Sr. Process Engineer is responsible for the development, improvement, validation, and support of semi-automated/fully automated manufacturing processes for production of biochemical products. Scope of responsibility included specifying, procuring, qualifying, troubleshooting, and maintaining equipment needed for processes for mixing, dispensing, and/or packaging biochemical components and/or products. May also be responsible for introducing new manufacturing technologies to support existing manufacturing processes and equipment; addresses daily technical issues and challenges in production and operations. May lead and/or support technology transfers to international or external manufacturing plants. Initiate continuous improvement opportunities utilizing methodologies; such as Lean/Six Sigma, DFM, SPC, etc. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485).
Here’ s where you’ ll demonstrate your competencies:
- Develop process windows/limits for manual and automated production processes;
- Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports;
- Respond to and solve daily technical issues in Irvine manufacturing;
- Disposition Non-conforming materials, determine root cause, and implement corrective action;
- Act as technical liaison between R&D Engineering and Manufacturing,
- Design, develop, implement, and improve manufacturing processes and equipment
- Introduce best in class manufacturing technologies to Irvine operations
- Create user-friendly, pictorial based manufacturing procedures with users in mind
- Train lab technicians, and manufacturing operators on processes and procedures
- Develop, implement, and support Lean processes in production and throughout operations;
- Lead/support continuous improvement projects and initiatives;
- Troubleshoot production line issues and customer complaints related to yield, quality, and throughput. Implement the appropriate robust containments and corrective actions on identification of root cause.
- Develop Process Failure Mode and Effects Analyses;
- Support supplier qualifications and assist in new supplier selection process;
- Continuously research, learn, and recommend best practices for world-class manufacturing;
- Maintain training records and always follow operating procedures;
- B.S./M.S./PhD in Engineering discipline, Chemical Engineering, Biochemical Engineering, Bioengineering, Bio-Medical, or MS/PhD in relevant scientific field with at least 4 years of experience in manufacturing, process development and characterization, process design and scale-up, improvement and validation.
- Experience with processing, dispensing, and packaging of biochemical products
- Experience working in bio-chemical laboratory and with general lab equipment
- Experience with Process Validation (IQ/OQ/PQ) and able to generate protocols and test reports
- Experience and ability to troubleshoot simple to complex manufacturing process issues
- Excellent conceptual, analytical, and problem-solving ability
- Experienced and skilled with data analysis including the use of statistical tools such as Minitab
- Excellent communication skills, both verbal and written, and the ability to effectively interface within a cross-functional teams.
- Skilled with CAD modeling software such as SolidWorks
- Experience working in an ISO13485, GMP, or FDA regulated environment is desirable.
- Experience with continuous improvement methodologies (ie, Lean, Six Sigma, OEE, )