Manufacturing Engineer II

At Kindeva – Lexington, KY, we make products that save lives, ensuring better health and well‑being for patients worldwide. The Manufacturing Engineer II is a pivotal role focused on optimizing equipment performance in a cGMP environment.

• Purpose‑driven work environment
• Significant growth potential
• Collaborative team culture
• Direct impact on patient care

Transform Lives Through Innovation – as Manufacturing Engineer II, you will optimize equipment performance, lead continuous improvement, and support GMP‑compliant manufacturing. Your work will directly enhance productivity, quality and cost efficiency.

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.

• 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.
• Identify and implement procedural or automation improvements for continuous optimization.
• 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.

• Bachelor’s degree in Engineering or related field with 2 or more years of experience in manufacturing engineering.
• Proven track record of implementing process improvements in a regulated manufacturing environment.
• Strong analytical and problem‑solving skills with a data‑driven mindset.
• Excellent communication and interpersonal skills for cross‑functional collaboration.
• Ability to manage multiple priorities in a fast‑paced environment.
• Preferred:
  Experience with automation, nasal drug delivery systems, or related device manufacturing.
• Knowledge of GMP, FDA regulations, and equipment qualification standards.
• Lean manufacturing or Six Sigma certification preferred.
• Proficiency in tools such as Smartsheet, Power BI, Power Apps, or similar platforms.

• Experience with automation, nasal delivery systems, or drug‑device combination products.
• Familiarity with GMP regulations and FDA/EMA compliance standards.
• Lean or Six Sigma certification.
• Proficiency in tools such as Smartsheet, Power BI, Power Apps, or similar platforms.

This is an opportunity to make a tangible impact on manufacturing excellence, product quality, and patient outcomes. You’ll work alongside passionate professionals in a collaborative environment that values innovation, accountability, and continuous improvement.

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.