Supervisor, Manufacturing Support ; overnight

About Civica

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 approximately one‑third of all U.S. hospital beds. Civica has supplied the U.S. Department of Veterans Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines, and currently supplies members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with payors, pharmacy‑benefit managers and pharmacies to enable significant cost savings to customers.

Civica’s new 140,000‑square‑foot manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables—drugs that are currently in or near shortage—as well as affordable biosimilar insulins, ensuring all Americans have access to lower‑cost, quality insulins.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. Its first commitment is to support Civica’s efforts to bring affordable insulin to all Americans.

Join us. Learn more at www.civicarx.org

The Supervisor, Manufacturing Support (Evening Shift, 6:00 PM – 6:30 AM) will play a role in facility start‑up and commercialization, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site. The position will hire, develop, and support a team of manufacturing associates through equipment qualifications, process improvement, equipment operation, and documentation ownership.

The supervisor will provide new process training to achieve efficient, cost‑effective, safe, and compliant production of quality injectable products according to Civica’s culture and vision of putting patients first.

• Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.
• Act as subject‑matter expert in manufacturing processes, including autoclaves, parts washers, clean‑in‑place (CIP), and material transfer isolators (MTIs).
• Serve as the escalation point for the group, taking accountability and ownership for business, technical, and compliance decisions.
• Maintain Civica’s right to operate:
  • Maintain inspection readiness and serve as SME during inspection tours.
  • Ensure staff are appropriately trained and qualified before execution.
  • Ensure systems and processes are properly executed and maintained to safeguard staff safety, product quality, and supply continuity.
• Develop and create SOPs, specifications, and governing documents that delineate manufacturing process requirements according to qualification, compliance, and business needs.
• Ensure the Manufacturing organization meets approved production plans at minimum cost while staying within quality limits and meeting FDA, cGMP, ISO, and OSHA requirements.
• Identify opportunities to improve customer service, quality, safety performance, process efficiencies, or reduce manufacturing costs using project‑management, cost‑control, Lean, and Six‑Sigma techniques.
• Mentor, coach, and teach Manufacturing Associates on change‑management/control techniques to ensure timely project completion.
• Use scientific methods and statistical tools to investigate, root‑cause analyze, and assess impacts for deviations or discrepancies.
• Lead CAPA projects, verify effectiveness through post‑project data collection and…