Manufacturing Engineering, Assembly

Manufacturing Engineer IIAt 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 cost efficiency. As a subject matter expert, you'll also play a key role in the design, installation, and commercialization of new equipment, ensuring readiness for GMP-compliant manufacturing and supporting the delivery of life-changing treatments.Growth OpportunityOur Lexington facility is experiencing exponential growth, offering exceptional opportunities for professional development and advancement. Responsibilities:Monitor and optimize manufacturing equipment performance in alignment with cGMP standards.Troubleshoot and resolve complex equipment issues to minimize production downtime.Lead lean manufacturing and Six Sigma initiatives to improve process efficiency and product quality.Support new product and equipment design reviews, process development, and staff training.Serve as a technical point of contact for clients and contract manufacturing services.Develop and maintain systems to visualize and analyze key performance indicators (KPIs).Support equipment-related deviations, CAPAs, and Change Controls as the equipment SME.Assist with Installation, Operational, and Performance Qualification (IOPQ) activities.Ensure equipment and processes meet regulatory requirements and are fit for commercial use. Oversee labeling, artwork changes, and packaging configurations as needed.Basic Qualifications:Bachelor's degree in Engineering or related field and/or equivalent experience2+ years of relevant experience in manufacturing with a focus on equipment and process improvement.Proficiency in CAD software, primarily AutoCAD to design and update comprehensive factory and work cell layouts.Create, maintain, and update detailed technical documents, including assembly instructions, work instructions (WIs), and standard operating procedures (SOPs).Proven track record of successfully implementing improvement initiatives in a manufacturing environment. Strong analytical and problem-solving skills with the ability to use data to drive decision-making.Ability to manage multiple projects and priorities in a fast-paced environment.Preferred Qualifications:Experience with automation, nasal, or related drug delivery device manufacture and packaging.Knowledge of GMP (Good Manufacturing Practices) and regulatory requirements in the pharmaceutical industry.Lean manufacturing or six sigma certificationsProficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc.This is an opportunity to make a tangible impact on manufacturing excellence, product quality, and patient outcomes. Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.