What are the responsibilities and job description for the Validation Engineer position at Civica Rx?
About Civica
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 industry leaders.
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 medications.
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 well-underway.
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. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Video Intro to Civica: https://vimeo.com/646267406
Job Description
The Validation Engineer will serve as the primary owner of executor of individual validation activities. You have a willingness to perform "hands-on" work in a dynamic, fast-paced work setting. Incumbent will establish in-depth knowledge of the products, processes, and related equipment in order to provide expertise and act as the single point of contact in the validation effort.
Essential Duties and Responsibilities
- Execute validation activity, from the initial drafting of requirements and protocols to final closure of projects
- Coordinate with the related groups (e.g., operations, engineering, laboratories) to execute the validation
- Support the ongoing refinement of validation procedures and processes
- 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 validation
Basic Qualifications and Capabilities
- A minimum of a bachelor’s degree in a relevant technical field is required (e.g., biology, microbiology, chemistry, etc.).
- An advanced degree, such as an M.S., is desired.
- General knowledge of the pharmaceutical industry, in particular drugs or biologics.4 year’s progressive experience in a manufacturing, quality, technical, or validation role at a pharmaceutical manufacturing/distribution facility, with at least 2 years of validation activity specifically.
- Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
- Experience with regulatory inspections is preferred. Experience with direct interface with inspectors is preferred.
- Experience in sterile parenteral manufacturing.
- Experience with the process of statistical sample plan establishment for process validation testing preferred.
PI29905567-25401-7ccab5f859b7
About the Company:
Civica Rx
