Company: Civica Rx
Posted on: January 26, 2023
Civica is a 501(c)(4) social welfare organization established in
2018 by health systems and philanthropies to reduce chronic generic
drug shortages and related high prices in the United States. Civica
is led by an experienced team of healthcare and pharmaceutical
Today, more than 55 health systems have joined Civica. They
represent over 1,500 hospitals and one-third of all U.S. hospital
beds. Civica has also begun to supply the U.S. Department of
Veteran's Affairs, the U.S. Department of Defense and the U.S.
Strategic National Stockpile of essential medicines.
Civica recently announced plans to expand its mission, via a unit
called CivicaScript, to into the outpatient pharmacy space and to
manufacture and distribute insulins that, once approved, will be
available to people with diabetes at significantly lower prices
than insulins currently on the market. The availability of Civica's
affordable insulins, beginning in 2024, will benefit people with
diabetes who have been forced to choose between life sustaining
medicines and living expenses, particularly those uninsured or
underinsured who often pay the most out of pocket for their
Civica's mission is to ensure that quality generic medications are
accessible and affordable to everyone. Since established, the #1
Policy for the Civica team has been "Do What Is in the Best
Interest of Patients." Civica's manufacturing facility in
Petersburg, Virginia, is the future home of affordable insulin and
essential sterile injectable medicines. The facility is currently
in late-stage construction and hiring for the site is
To find out more about how Civica's innovative model is directly
impacting patient care, click here to read a summary from the New
England Journal of Medicine. (
To learn more about Civica's plans to bring affordable insulin to
Americans living with diabetes, click here to read an article in
Video Intro to Civica: https://vimeo.com/646267406
The Manufacturing Facilitator II will develop and support the
Manufacturing team by participating in equipment qualifications,
identifying and implementing process improvements through process
monitoring, conducting investigations, and impact assessments. Will
provide new process training to the manufacturing team to achieve
efficient, cost-effective, safe, and compliant production of
quality injectable products according to the Civica culture and
vision of what is in the best interest of the patient.
Essential Duties and Responsibilities
Under the Manufacturing Manager's direction, actively participate
in new equipment and process qualifications.
Develop and create standard operating procedures, specifications,
and other forms of governing documents to delineate manufacturing
process requirements according to qualification, compliance, and
Ensure that the Manufacturing organization operates to meet the
requirements of approved production plans at minimum costs within
established quality limits and in accordance with FDA, cGMP, ISO,
and OSHA requirements.
Responsible for identifying opportunities to improve customer
service, quality, safety performance, scrap minimization, or
otherwise reduce manufacturing costs by using effective project
management, cost control techniques, and Lean Manufacturing.
Mentors, coaches, and teaches Manufacturing Associates in the use
of statistical tools, Lean/Six Sigma methodologies, and change
management/control techniques to ensure timely completion of
projects at the expected results.
Utilizes scientific methods and statistical tools to perform
investigations, root cause analyses, and impact assessments in
support of timely resolution of deviations/discrepancies related to
Identify corrective and preventive actions (CAPA), lead project to
completion within project timelines. Verify effectiveness of CAPA
by post-project data collection and analysis.
Demonstrated ability to act as subject matter expert in
manufacturing equipment build and function, as well as in
manufacturing processes, including aseptic filling, isolator/RABs
technology, terminal sterilization, and packaging (serialization
Minimum Qualifications (Knowledge, Skills, and Abilities)
Advanced experience in a process improvement environment including
project management, change management and leading Lean/Six Sigma
Lean Manufacturing/Six Sigma Green Belt Certification
Expert facilitation skills with demonstrated results.
Demonstrated excellence in oral and written communication.
5+ years demonstrated ability in a GMP FDA, cGMP, ISO, or other
regulated production environments.
Bachelor's degree; Equivalent education and experience may be
Keywords: Civica Rx, Richmond , Manufacturing Facilitator, Other , Petersburg, Virginia
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