Validation Lead - Process and APS
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 Aseptic Validation Lead will support, coordinate, and execute
validation activities with an emphasis on process validation and
aseptic process simulation. The validation efforts will be executed
in compliance with appropriate guidelines, specifications, and
internal procedures. This role will lead the initial validation
efforts in a new Sterile Injectable Facility and therefore includes
initial procedure and policy design in relation to the validation
activities. As needed, the role may also expand to provide support
to other areas of the validation group.
Essential Duties and Responsibilities
As the Aseptic Validation Lead, the incumbent must be prepared to
operate in a leadership role to successfully drive the process and
APS activities. You have a willingness to perform "hands-on" work
in a dynamic, fast-paced work setting. Incumbent provides technical
expertise on Manufacturing and Compliance standards and processes
to team members; and provides input on strategy to key business
Execute process validation activity, from initial drafting of
protocols to final closure of projects.
Execute APS and process validation activity. This includes both
initial runs as part of original site validation and product
qualification as well as later periodic re-validation activity.
Support the development of policies, procedures, templates and
other documents in the design of the process and APS validation
Understand and apply the understanding of FDA and Quality System
Requirements in carrying out duties.
Provide leadership and mentoring to other members of the validation
group, as applicable.
Effectively interact and collaborate with cross-functional
departments and vendors in order to meet company expectations.
Serve as subject matter expert in process and APS validation.
Basic Qualifications and Capabilities
A minimum of a bachelor's degree in a relevant technical field is
required (e.g., engineering biology, chemistry, etc.). Advanced
degree, such as an M.S., is desired.
6+ year's progressive experience in a manufacturing, quality,
technical, or validation role at a pharmaceutical manufacturing /
distribution facility, with at least 3 years of validation activity
specifically within Process and/or APS validation.
Validation experience with Aseptic Process Simulation is strongly
preferred (also referred to as Media Fill validation).
Experience with the process of statistical sample plan
establishment for process validation testing preferred.
Experience working in cGMP environments that meet FDA, ICH
guidelines, local regulations, and industry best practices.
Experience with regulatory inspections is preferred. Experience as
direct SME interface with inspectors is preferred.
Experience in aseptic sterile parenteral manufacturing.
General knowledge of the pharmaceutical industry, in particular
drugs or biologics.
Leadership experience in validations, including cross functional
coordination with other impacted organizations such as
manufacturing and testing laboratories.
Keywords: Civica Rx, Richmond , Validation Lead - Process and APS, Other , Petersburg, Virginia
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