Validation Engineer I

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

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

As a Validation Engineer, you will play a critical role in ensuring our pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activities—including equipment, utilities, facilities, and process validations—to ensure our operations remain compliant and inspection-ready. Your expertise in cGMP, risk-based validation, and technical writing will directly impact the safety, efficacy, and consistency of the drug products we deliver. This is a highly visible, hands‑on role ideal for a detail‑oriented professional passionate about quality and continuous improvement in a dynamic, fast‑paced environment

Responsibilities:

Validation Strategy & Execution

• 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.

Compliance & Risk Management

• 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.

Continuous Improvement

• 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.

Qualifications:

• Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience with a strong maintenance/engineering background or GxP.

• Strong maintenance/engineering background or GxP
• 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 Qualifications:

• Familiarity with validation of automated systems and computerized system validation (CSV).
• Demonstrated knowledge of FDA, EU, and ICH regulatory requirements including 21 CFR Part 11 and Annex 15.
• 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.

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