Validation Engineer II

Validation Engineer II (543) –
Civica Rx

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all‑time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. Civica is a market‑based nonprofit solution created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one‑third of all U.S. hospital beds.

Civica supplies medicines to members in 49 states and supports national programs including the Veterans Affairs, Department of Defense, and Strategic National Stockpile. The organization supports affordable generics and biosimilars and aims to reduce high drug prices for patients.

The Validation Engineer II will lead the commissioning, qualification, and validation (CQV) of new and modified equipment, facilities, utilities, products, and processes. Working closely with system owners and stakeholders in Operations, Engineering, Laboratories, IT, and Quality Assurance, the role guides CQV activities to a compliant state, authors and reviews CQV documentation, and serves as subject matter expert.

• Lead the development and execution of commissioning, qualification, and validation protocols for equipment and systems.
• Manage all phases of CQV, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Execute validation activities in a timely manner, ensuring project completion without delays.
• Evaluate system change controls for validation impact and support change qualification through relevant actions.
• Develop standard operating procedures for new processes and equipment.
• Manage interactions across functions and communicate with vendors as needed.
• Serve as Principal Investigator for validation‑related excursions.
• Contribute to continuous improvement of validation processes and procedures.

• Bachelor’s degree in engineering or relevant sciences and 8+ years of CQV experience.
• 8 years’ experience with sterile injectables, combo‑devices, or biologics.
• Advanced degrees or certifications relevant to the role are a plus.
• Knowledge of regulatory requirements (cGMP, FDA, etc.).
• Experience authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
• Self‑directed with strong problem‑solving, analytical, and technical skills.
• Strategic and tactical thinking with attention to detail.
• Strong collaborative and influencing skills in a cross‑functional, matrixed environment.
• Leadership ability to take ownership and follow through on projects.
• Ability to work in a fast‑paced team environment, meet deadlines, and prioritize work.
• Experience in a process improvement environment, including change management and Lean/Six Sigma project teams.
• Autonomous work within established guidelines, procedures, and practices.

• Experience in a sterile fill‑finish facility.
• Experience with single‑use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Start‑up experience preferred.
• Experience with validation tools and processes, including temperature mapping and Kaye Validator.