Validation Lead – Process And APS

About Civica

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration’s shortage list. Manufacturing challenges and predatory pricing are both the cause and result.

Who suffers most? Patients.

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. Led by an experienced team of health care and pharmaceutical industry leaders.

Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent 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 is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.

To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.

https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189

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.