Manufacturing Manager Vial Fill – 1st Shift

Join us as a Manufacturing Manager Vial Fill (#922) – 1st Shift at Civica Rx.

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare, with over 300 medications currently in shortage, according to industry and FDA reports.

Civica is a market-based nonprofit established in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. We serve nearly 60 health systems, over 1,400 hospitals, and supply medicines to various U.S. government agencies. Our new manufacturing facility in Virginia will produce essential sterile injectables and affordable biosimilar insulins, ensuring access for all Americans.

The Manager, Manufacturing, Vial Fill, will support daily manufacturing operations at our Petersburg, VA site, focusing on equipment qualification, process improvements, investigations, and team development. The role aims to ensure efficient, safe, and compliant production of quality injectable products aligned with Civica’s mission to serve patients.

• Participate in equipment and process qualifications under the Director of Manufacturing’s guidance.
• Create and maintain SOPs, specifications, and governing documents for manufacturing processes.
• Ensure operations meet production plans, quality standards, and comply with FDA, cGMP, ISO, OSHA regulations.
• Identify opportunities for improvement in customer service, quality, safety, and cost reduction using project management and Lean methodologies.
• Mentor and train team members in statistical tools, Lean/Six Sigma, and change management.
• Perform investigations and root cause analyses using scientific and statistical methods.
• Lead CAPA projects and verify their effectiveness.
• Act as subject matter expert in manufacturing equipment and processes, including aseptic filling and packaging.

• Bachelor's degree and 8+ years of experience in regulated manufacturing environments; equivalent education and experience considered.
• Experience in process improvement, project management, and Lean/Six Sigma; certification is a plus.
• Prior experience in high-speed vial or finish fill/finish operations required.
• Strong facilitation, communication, analytical, and problem-solving skills.

Regularly required to speak, hear, handle objects, and use hands. Occasionally stand, walk, sit, reach, and lift up to 40 pounds. Noise level is low to moderate. Reasonable accommodations available.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job functions:
  
  Management and Manufacturing
• Industry: Pharmaceutical Manufacturing