Validation Engineer II

Job Description

About Civica:

In the last 20 years, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to alleviate chronic drug shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. Their guiding principle is to “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission to include reducing pharmacy costs through its sister organization, CivicaScript, and is developing affordable biosimilar insulin to support those in need.

Position Summary

The Validation Engineer II will lead commissioning, qualification, and validation (CQV) efforts for new and modified equipment and processes. This role involves collaborating with various stakeholders, authoring and executing CQV documentation, and serving as a subject matter expert.

Essential Duties and Responsibilities:

• Lead development and execution of CQV protocols.
• Manage all phases of CQV activities, ensuring timely project completion.
• Evaluate System Change Controls for validation impact.
• Support the creation of Standard Operating Procedures.
• Serve as Principal Investigator for validation excursions.
• Contribute to continuous improvement of validation processes.

Basic Qualifications:

• Bachelor’s degree in engineering or relevant sciences with 8+ years of CQV experience.
• Experience with sterile injectables or biologics.
• Knowledge of regulatory requirements (cGMP, FDA).
• Strong problem-solving and analytical skills.
• Ability to work collaboratively in a fast-paced environment.

Preferred Qualifications:

• Experience in a sterile fill-finish facility.
• Start-up experience preferred.
• Familiarity with validation tools and processes.