Senior Validation Engineer: Pharma Quality & Compliance

Kindeva Drug Delivery; Lexington (KY); On-site; USD 80,000 - 110,000; Full time

Job summary

Kindeva Drug Delivery in Lexington, Kentucky, is looking for a Validation Engineer. This role ensures compliance with FDA and global regulations in pharmaceutical manufacturing processes. Responsibilities include developing validation protocols, supporting commissioning activities, and maintaining documentation. Candidates should have a Bachelor’s degree in engineering or life sciences and at least 5 years of relevant experience. Familiarity with automated systems and validation tools is preferred. Kindeva is committed to quality and continuous improvement in a fast-paced environment.

Qualifications

• 5+ years of validation experience in pharmaceuticals, biotech, or medical devices.
• Knowledge of FDA, EU, and ICH regulations including 21 CFR Part 11 and Annex 15.
• Experience with computerized system validation and automated systems.

Responsibilities

• Develop and maintain validation protocols and reports for manufacturing processes.
• Support commissioning and qualification activities for new equipment.
• Author and review validation lifecycle documentation.

Skills

Validation documentation development

Regulatory compliance knowledge

Strong organizational skills

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in engineering, life sciences, or related field

Tools

TrackWise

ValGenesis

Veeva

Job description

Kindeva Drug Delivery in Lexington, Kentucky, is looking for a Validation Engineer. This role ensures compliance with FDA and global regulations in pharmaceutical manufacturing processes. Responsibilities include developing validation protocols, supporting commissioning activities, and maintaining documentation. Candidates should have a Bachelor’s degree in engineering or life sciences and at least 5 years of relevant experience. Familiarity with automated systems and validation tools is preferred. Kindeva is committed to quality and continuous improvement in a fast-paced environment.