Senior Validation Engineer

1w1 week ago

Kindeva Drug Delivery

Lexington, US · Full-time · $110,000 – $150,000

About this role

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. As a Senior Validation Engineer, you will play a critical role in ensuring pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activities for equipment, utilities, facilities, and processes to keep operations compliant and inspection-ready.

Your expertise in cGMP, risk-based validation, and technical writing will impact the safety, efficacy, and consistency of drug products. Develop, execute, and maintain validation protocols and reports including IQ, OQ, PQ. Author and review validation lifecycle documentation such as plans, protocols, deviations, and final reports.

Partner with Engineering, Manufacturing, Quality, and Regulatory Affairs for effective cross-functional validation planning and execution. This highly visible, hands-on role suits detail-oriented professionals passionate about quality in a dynamic, fast-paced environment. Perform periodic reviews, revalidation, risk assessments like FMEA, and support change control and CAPA.

Act as subject matter expert during internal and external audits and inspections. Evaluate validation program effectiveness and recommend improvements for compliance, efficiency, and scalability. Stay current with industry best practices and evolving regulatory guidance.

Requirements

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

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
Act as subject matter expert (SME) during internal and external audits and inspections