Junior Validation Engineer: Quality, Compliance & Impact

Kindeva; Lexington (KY); On-site; USD 75,000 - 105,000; Full time

Job summary

Kindeva is seeking a Validation Engineer to lead and execute validation activities across equipment, utilities, facilities, and processes. You will ensure compliance with FDA and global standards, author validation documents, and drive continuous improvement in a fast-paced manufacturing environment.

Ideal candidates have a strong maintenance/engineering background, knowledge of GxP, and proven experience in IQ/OQ/PQ, risk assessment, and change control.

Qualifications

• Bachelor’s degree with 2+ years of related experience, or advanced degree.
• Strong maintenance/engineering background or GxP.
• Experience in developing and executing validation documentation (IQ/OQ/PQ, protocols, reports).
• Excellent organizational, communication, and technical writing skills.

Responsibilities

• Develop, execute, and maintain validation protocols and reports (IQ, OQ, PQ) for equipment, utilities, and manufacturing processes.
• Support commissioning and qualification activities for new equipment and facilities, ensuring regulatory compliance with FDA, EU, and global expectations.
• Author and review validation lifecycle documentation, including plans, protocols, deviations, and final reports.
• Partner with Engineering, Manufacturing, Quality, and Regulatory Affairs to ensure cross‑functional validation planning and execution.
• Perform periodic reviews and revalidation activities in accordance with lifecycle requirements.

Skills

GxP

IQ/OQ/PQ docs

Cross-functional collab

Technical writing

Education

Bachelor’s degree in related field

Advanced degree (MS/PhD)

Tools

TrackWise

ValGenesis

Veeva

Job description

Kindeva is seeking a Validation Engineer to lead and execute validation activities across equipment, utilities, facilities, and processes. You will ensure compliance with FDA and global standards, author validation documents, and drive continuous improvement in a fast-paced manufacturing environment.

Ideal candidates have a strong maintenance/engineering background, knowledge of GxP, and proven experience in IQ/OQ/PQ, risk assessment, and change control.