Kindeva Drug Delivery · 1 day ago
Senior Manufacturing Engineering II
Lexington, KY
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKindeva Drug Delivery is dedicated to making products that save lives and enhance patient well-being. The Senior Manufacturing Engineer II will drive manufacturing excellence through process optimization and equipment innovation, while collaborating cross-functionally to improve operational performance and product reliability.
Manufacturing
Responsibilities
Lead efforts to monitor and optimize the performance of manufacturing equipment ensuring compliance with CGMP standards
Troubleshoot and resolve complex issues to minimize production downtime
Identify and implement opportunities for continuous improvement through upgrades, process modification, or alternative solutions. Lead in the development and implementation of procedural or automation improvement changes
Lead lean manufacturing initiatives, six sigma projects, and other process optimization efforts to improve productivity, quality, and cost efficiency
Assist with new product / equipment design reviews, process development and commercialization activities including training and development of manufacturing staff on operation and process
Serve as a technical point of contact for client and contract services
Develop and maintain measurement systems to visualize manufacturing key performance indicators (KPIs)
Use data analytics tools and techniques to analyze equipment performance, identify trends, and recommend corrective action and process improvement
Assist with manufacturing equipment-related deviations and root cause analysis as the equipment SME
Support the development and execution of Corrective and Preventive Actions (CAPA) and Change Controls to address root causes of equipment failures and performance issues
Support equipment Installation, Operation, and Performance Qualification (IOPQ) activities
Experience supporting client and regulatory audits as well as responding to action items
Provide SME input on equipment qualification processes, ensuring fit for commercial manufacturing use, compliance with FDA and other regulatory requirements
Qualification
Required
Bachelor's degree in Engineering or related field and/or equivalent experience
8+ years of manufacturing of relevant experience in the pharmaceutical industry with a Bachelor's degree; and 6+ years' experience in the pharmaceutical industry and a Master's degree or a PhD with 3 years in the pharmaceutical industry and a focus on equipment and process improvement
Proven track record of successfully implementing improvement initiatives in a pharmaceutical manufacturing environment
Strong analytical and problem-solving skills with the ability to use data to drive decision-making
Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across multiple departments
Ability to manage multiple projects and priorities in a fast-paced environment
Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal
Experience with automation, nasal, or related drug delivery device manufacture and packaging
Preferred
Lean manufacturing or Six Sigma certifications
Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc
Experience with site-level automation systems, ex. Serialization - Antares, Tracelink, Data historian – Aveva OSI PI, Reporting Systems – OSI PI, MS Report Builder, SQL Development, Kepware, Matrikon, AB Factory Talk, Automated Visual Inspection
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