Validation Engineer II

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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 currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market‑based nonprofit solution created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages.

Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and about one‑third of all U.S. hospital beds. Civica supplies medicines to members in 49 states and serves critical agencies such as the U.S. Department of Veterans Affairs, the Department of Defense, and the Strategic National Stockpile. Civica’s mission has expanded to include the CivicaScript program, which delivers affordable quality outpatient generics directly to consumers.

A new 140,000 square‑foot manufacturing facility in Virginia will produce sterile injectables and biosimilar insulins.

The Validation Engineer II will lead commissioning, qualification, and validation (CQV) activities for new and modified equipment, facilities, utilities, products, and processes to support project, operations, and quality objectives. The role collaborates with system owners and stakeholders in Operations, Engineering, Laboratories, IT, and Quality Assurance, guiding CQV activities to compliance throughout their lifecycle, authoring, reviewing, and executing CQV documentation and related procedures.

• Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.
• Responsible for all phases of CQV activity—including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Execute validation activity in a timely manner, proactively pursuing details to ensure project completion without avoidable delays.
• Evaluate system change controls for validation impact and support change qualification through relevant change actions.
• Support development of standard operating procedures for new processes and equipment.
• Manage interactions across functions within the site and communicate with system 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 strong attention to detail.
• Collaborative and influencing skills; works well in a cross‑functional, matrixed environment.
• Leadership to take ownership and follow through on assigned projects.
• Ability to work in a fast‑paced team environment, meet deadlines, and prioritize work.
• Experience in process improvement, including change management and participation in Lean/Six Sigma projects.
• Ability to work autonomously 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 use of Kaye Validator.

Mid‑Senior level

Full‑time

Quality Assurance

Healthcare/Pharmaceuticals

Richmond, VA ($93,000.00‑$)

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