Kindeva Drug Delivery · 3 days ago
Senior Process Development Engineer II
Lexington, KY
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKindeva Drug Delivery is a rapidly expanding pharmaceutical CDMO that makes products that save lives. As a Senior Process Development Engineer, you will lead the transfer of pharmaceutical products and manufacturing processes between R&D and commercial manufacturing sites, ensuring processes are scalable and compliant with regulatory standards.
Manufacturing
Responsibilities
Plan and execute technology transfer activities for drug products or devices from R&D to manufacturing or between commercial sites
Author and/or review tech transfer documentation (e.g., process descriptions, gap assessments, risk assessments, readiness assessments, protocols)
Translate lab-scale processes into commercial manufacturing processes
Support scale-up activities and resolve technical issues during manufacturing
Work with R&D to adapt and optimize processes for commercial equipment
Implement process improvements to enhance product quality, yield, and efficiency
Ensure all tech transfer activities are documented per regulatory requirements
Support regulatory submissions and inspections/audits
Draft production documentation including batch records and protocols
Support validation and qualification efforts (process, equipment, cleaning)
Serve as technical liaison between engineering, R&D, manufacturing, QA, and regulatory
Coordinate with customers, vendors, and external partners
Train manufacturing staff on transferred processes
Facilitate knowledge transfer and review development history
Troubleshoot and escalate risks with proposed mitigation strategies
Ensure effective and compliant transfer of knowledge, data, and technology
Apply scientific and statistical methods to analyze and diagram production processes
Lead structured problem-solving to identify root causes and develop solutions
Drive Risk Management tools like Fault Tree Analysis and FMEA
Address diverse technical problems requiring informed judgment and adaptive techniques
Provide technical leadership and guidance to others as a subject matter expert
Qualification
Required
BS in engineering/related degree or equivalent experience
8+ years of related experience with a bachelor's degree; or 6 years with a master's degree, or 3 years and a PhD
Previous work experience in GMP pharmaceutical manufacturing and technical transfers
Working knowledge of cGMP, GAMP5, and regulatory requirements
Preferred
Experience working with nasal spray products/devices or related drug-delivery technologies
Strong technical and nontechnical communication skills
Experience supporting client/regulatory audits and follow-up responses
Extensive technical writing experience
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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