Validation Engineer

Kindeva Drug Delivery • Lexington, KY

128d

About The Position

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. As a Validation Engineer, you will play a key role in supporting the qualification and validation activities that ensure our manufacturing processes and equipment meet rigorous regulatory and quality standards. Your expertise will help maintain compliance with cGMP and industry guidelines, contributing to the reliable production of safe and effective pharmaceutical products. You will collaborate closely with cross-functional teams to execute validation protocols and ensure smooth technology transfers.

Requirements

• BS in engineering, related degree, or equivalent experience
• 4 years of related experience, or 3 years with a Master’s degree

Nice To Haves

• Previous work experience in a GMP manufacturing environment
• Working knowledge of cGMP, GAMP5, and regulatory requirements
• Experience working with nasal spray products, devices, or related drug-delivery systems
• Effective oral and written communication skills
• Technical writing experience including SOPs, maintenance PMs, user requirement specifications, design qualifications, and traceability matrices
• Supporting regulatory agency inspections or audits.

Responsibilities

• Develop, execute, and review validation protocols for equipment, processes, and utilities in a GMP manufacturing environment.
• Support installation, operational, and performance qualification (IQ/OQ/PQ) activities to ensure equipment and systems meet design specifications.
• Assist in the development and maintenance of validation documentation, including protocols, reports, and traceability matrices.
• Collaborate with manufacturing, quality, engineering, and other stakeholders to ensure validation requirements are met.
• Participate in risk assessments and change control processes related to validation activities.
• Support continuous improvement initiatives for validation strategies and documentation.
• Ensure compliance with cGMP, GAMP5, and regulatory expectations throughout the validation lifecycle.
• Communicate validation status and issues effectively through written reports and verbal updates.
• Assist in training team members on validation procedures and standards.

What This Job Offers

• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees