Kindeva Drug Delivery

JOB TITLE & Employer Name: Principal Process Engineer for Kindeva Drug Delivery LP. LOCATION: 19901 Nordhoff St., Northridge, California 91324. JOB DUTIES: Provide technical support to process improvement initiatives on existing and new process lines. Act as a subject matter expert in the implementation and improvement of automated solutions to improve equipment's uptime and efficiency. Perform Design of experiment (DOE) & Statistical process control (SPC) to improve process using Minitab. Process improvement using Lean manufacturing tools, such as Kaizen, Value stream mapping (VSM), Single minute exchange die (SMED), FMEA, TPM & Poka-yoke. Expert in 21 CFR Part 820 & 21 CFR Part 11 rules. Perform root cause analysis (RCA) investigation on quality deviation and execute CAPA on time. Develop and define User Requirement specification (URS) for new process equipment. Work in conjunction with the product development team to define the commercial...

Our Work Matters At Kindeva, we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: The Senior Manufacturing Engineer is responsible for the design, implementation, optimization, troubleshooting, and lifecycle management of aseptic manufacturing processes and equipment used in the production of sterile pharmaceutical and/or biopharmaceutical products. The role requires a strong focus on driving quality into production processes, implementation of best practices, and continuous improvement. This role plays a key technical role in maintaining sterility assurance, driving equipment reliability, supporting regulatory compliance (cGMP, EU Annex 1), and leading or significantly contributing to process improvements, automation enhancements, and validation activities in ISO 5/Grade A cleanroom environments. Responsibilities: Aseptic Manufacturing & Equipment Engineering Effectively manage and...

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. Why Kindeva? Purpose-driven work environment Significant growth potential Collaborative team culture Direct impact on patient care Industry-leading innovation At Kindeva - Lexington, KY, we're not just making products - we're manufacturing life-saving nasal spray medications that make a difference. The Impact You Will Make: Transform Lives Through Innovation As a Manufacturing Engineer II , you will be at the forefront of optimizing equipment performance and driving continuous improvement across our pharmaceutical production lines. You will lead troubleshooting efforts, implement lean manufacturing initiatives, and support equipment qualification activities to ensure seamless, compliant operations. Your ability to analyze data, resolve complex issues, and collaborate across teams will directly enhance productivity, quality, and...