Civica Rx
Manufacturing Manager Vial Fill (#922) – 1st Shift
Civica Rx, Virginia State University, Virginia, us, 23806
Manufacturing Manager Vial Fill (#922) – 1st Shift
Join us as a
Manufacturing Manager Vial Fill (#922) – 1st Shift
at
Civica Rx . About Civica
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. Job Description
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. Essential Duties
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. Minimum Qualifications
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. Physical Demands & Work Environment
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. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job functions: Management and Manufacturing Industry: Pharmaceutical Manufacturing
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Join us as a
Manufacturing Manager Vial Fill (#922) – 1st Shift
at
Civica Rx . About Civica
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. Job Description
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. Essential Duties
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. Minimum Qualifications
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. Physical Demands & Work Environment
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. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job functions: Management and Manufacturing Industry: Pharmaceutical Manufacturing
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