Validation Lead - Process and APS

Company: Civica Rx
Location: Petersburg
Posted on: January 26, 2023

Job Description:

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 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 leaders.

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 activities.

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.

PI201562068

Keywords: Civica Rx, Richmond , Validation Lead - Process and APS, Other , Petersburg, Virginia