Kindeva Drug Delivery · 4 months ago
Senior Automation Engineer II
Lexington, KY, USA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKindeva Drug Delivery is dedicated to creating products that save lives and improve patient health globally. As a Senior Automation Engineer, you will design, implement, and maintain automated systems for pharmaceutical manufacturing, ensuring efficiency and compliance in a cGMP environment.
Manufacturing
Responsibilities
Design, develop, and implement automated systems, including software, hardware, and processes
Analyze existing systems, identify areas for automation, and create solutions that meet specific needs
Configure and/or manage site-level automation systems (e.g., serialization, data historian, reporting, industrial networking)
Lead the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities, including authoring and/or reviewing IQ/OQ/PQ protocols, test execution, and authoring summary reports
Support the development of site automation standardization and/or technology master plans
Write scripts and code to automate tasks, processes, and workflows using various programming languages
Test and optimize automated systems to ensure they function correctly and efficiently
Identify and resolve issues and continuously improve system performance
Implement improvements to existing equipment used to manufacture and package multiple types of nasal spray drug products
Troubleshoot and resolve issues with automated systems, ensuring they operate smoothly
Diagnose problems, implement fixes, and perform maintenance tasks
Support maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, execution of automation-related PMs (e.g., backup/restore), and support of out-of-tolerance investigations related to instrument calibrations
Collaborate with other engineers, technicians, and stakeholders to develop and implement automation solutions
Effectively communicate technical information and ensure project success
Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls, and CAPAs through participation on cross-functional teams
Participate in plant engineering, maintenance, and calibration activities as needed
Other duties as assigned
Qualification
Required
BS in engineering/related degree or equivalent experience
8+ years of related experience; or 6 years with a master's degree, or 3 years with a PhD
Experience with a variety of PLCs, HMI hardware, and industrial sensors and applications
Controls design experience
General electrical design knowledge
Working knowledge of cGMP, GAMP5, and regulatory requirements
Technical writing experience such as: SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal
Preferred
Minimum of 8 years of previous work experience in a related field
Experience working with nasal spray products and devices or related drug-delivery devices
Industrial networking and server management
Experience with site-level automation systems such as: 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
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