Manufacturing Engineer II

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well‑being for patients around the world.

• Collaborative team culture
• Direct impact on patient care

At Kindeva – Lexington, KY, we're not just making products – we're manufacturing life‑saving nasal spray medications that make a difference.

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.

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.

Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well‑being for patients worldwide.

Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.

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.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!

Job Family B - Engineering - Manufacturing Engineering