Kindeva Drug Delivery · 2 days ago
Sr. Validation Engineer
Lexington, KY
Full-time
Onsite
Senior Level
5+ years expKindeva Drug Delivery is dedicated to creating products that enhance health and well-being for patients globally. The role of Validation Engineer involves leading and executing validation activities to ensure compliance with rigorous regulatory and quality standards in pharmaceutical manufacturing.
Manufacturing
Responsibilities
Develop, execute, and maintain validation protocols and reports (IQ, OQ, PQ) for equipment, utilities, and manufacturing processes
Support commissioning and qualification (C&Q) activities for new equipment and facilities, ensuring compliance with FDA, EU, and global regulatory expectations
Author and review validation lifecycle documentation, including plans, protocols, deviations, and final reports
Partner with Engineering, Manufacturing, Quality, and Regulatory Affairs to ensure effective cross-functional validation planning and execution
Perform periodic reviews and revalidation activities in accordance with lifecycle requirements
Lead risk assessments (FMEA, gap assessments) to determine validation strategy and appropriate testing requirements
Provide validation input during change control, deviation investigations, and CAPA execution
Ensure data integrity and good documentation practices in all validation records
Act as subject matter expert (SME) during internal and external audits and inspections
Evaluate validation program effectiveness and recommend process improvements to enhance compliance, efficiency, and scalability
Stay current with industry best practices and evolving regulatory guidance to ensure validation activities remain aligned with expectations
Qualification
Required
Bachelor's degree in engineering, life sciences, or a related technical field
5 or more years of validation experience; or 3 years with a Master's degree in a regulated pharmaceutical, biotech, or medical device environment
Demonstrated knowledge of FDA, EU, and ICH regulatory requirements including 21 CFR Part 11 and Annex 15
Experience in developing and executing validation documentation (IQ/OQ/PQ, protocols, reports)
Strong organizational, communication, and technical writing skills
Ability to collaborate cross-functionally and manage multiple priorities in a deadline-driven environment
Preferred
Familiarity with validation of automated systems and computerized system validation (CSV)
Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation
Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva)
Lean Six Sigma or other continuous improvement training/certifications
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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