Kindeva Drug Delivery · 15 hours ago
Validation Engineer
Lexington, KY
Full-time
Onsite
Mid Level
3+ years expKindeva Drug Delivery is dedicated to creating products that save lives and improve patient health globally. As a Validation Engineer, you will support qualification and validation activities to ensure compliance with regulatory standards in manufacturing processes, collaborating with cross-functional teams to execute validation protocols.
Manufacturing
Responsibilities
Develop, execute, and review validation protocols for equipment, processes, and utilities in a GMP manufacturing environment
Support installation, operational, and performance qualification (IQ/OQ/PQ) activities to ensure equipment and systems meet design specifications
Assist in the development and maintenance of validation documentation, including protocols, reports, and traceability matrices
Collaborate with manufacturing, quality, engineering, and other stakeholders to ensure validation requirements are met
Participate in risk assessments and change control processes related to validation activities
Support continuous improvement initiatives for validation strategies and documentation
Ensure compliance with cGMP, GAMP5, and regulatory expectations throughout the validation lifecycle
Communicate validation status and issues effectively through written reports and verbal updates
Assist in training team members on validation procedures and standards
Qualification
Required
BS in engineering, related degree, or equivalent experience
3 years of related experience, or 2 years with a Master's degree
Preferred
Previous work experience in a GMP manufacturing environment
Working knowledge of cGMP, GAMP5, and regulatory requirements
Experience working with nasal spray products, devices, or related drug-delivery systems
Effective oral and written communication skills
Technical writing experience including SOPs, maintenance PMs, user requirement specifications, design qualifications, and traceability matrices
Supporting regulatory agency inspections or audits
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
2026-01-16
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