Supplier Process Engineer II

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 Supplier Process Engineer, you will play a pivotal role in ensuring the quality and reliability of materials that drive pharmaceutical production. You will lead the Material Review Board and Material Change Control Board processes, oversee supplier evaluations and qualifications, and support supplier investigations to uphold the highest standards. Your ability to analyze and communicate material-related issues through reports, memos, and presentations will strengthen supplier partnerships and drive continuous improvement. With a broad scope of impact, you will contribute to every aspect of supplier processes, ensuring seamless operations and the successful delivery of life-changing treatments. Growth Opportunity Our Lexington facility is experiencing exponential growth, offering exceptional opportunities for professional development and advancement. Join us during this exciting expansion phase and grow your career while contributing to meaningful healthcare solutions.   Responsibilities: Develop and execute Supplier Process Engineering protocols to ensure compliance with MMT specifications, medical device regulations and cGMP. Investigate and resolve supplier quality issues, leading root cause analysis and corrective actions. Manage supplier documentation and the ERP system to align with production processes. Lead vendor complaints, change management meetings, and new client onboarding, including material sourcing, vendor qualifications, and specification reviews. Oversee labeling, artwork changes, and packaging configurations as needed. Qualifications: Bachelor’s degree in an engineering-related field with 2-4 years of experience in pharmaceutical manufacturing or quality engineering (medical device/component field preferred). Knowledge of cGMPs, FDA guidelines, ISO standards, ASTM standards, and other regulatory requirements. Strong analytical skills for problem-solving, data collection, and root cause analysis. Understanding statistical concepts, probability, and process capabilities.  Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access, Project) and statistical software (Minitab, Stat Graphics, PH Stat, Etc.). Ability to interpret technical instructions, component and assembly drawings, and GD&T symbols. Excellent communication skills for writing reports, procedures, and responding to inquiries from customers and regulatory agencies. Preferred: Six Sigma and Lean Manufacturing training. Experience with medical device processes and materials is a plus. Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide. # LI-Onsite