Kindeva Drug Delivery · 3 days ago
Manufacturing Engineer II
Lexington, KY
Full-time
Onsite
Entry, Mid Level
2+ years expKindeva Drug Delivery is dedicated to making products that save lives, ensuring better health for patients globally. As a Manufacturing Engineer II, you will optimize equipment performance and drive continuous improvement in pharmaceutical production lines, directly enhancing productivity and quality while supporting the delivery of life-changing treatments.
Manufacturing
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
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
Qualification
Required
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
Knowledge of GMP, FDA regulations, and equipment qualification standards
Preferred
Experience with automation, nasal drug delivery systems, or related device manufacturing
Lean manufacturing or Six Sigma certification
Proficiency in tools such as Smartsheet, Power BI, Power Apps, or similar platforms
Familiarity with GMP regulations and FDA/EMA compliance standards
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
MarketScreener
2026-01-01
Company data provided by crunchbase