What are the responsibilities and job description for the Validation Technician position at Civica Rx?
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 Validation Technician will execute and support validation activities. The validation efforts will be executed in compliance with appropriate guidelines, specifications, and internal procedures. This role is applicable to all validation activity such as equipment, methods, processes, computer systems, and/or cleaning.
Essential Duties and Responsibilities:
The Validation Technician will serve as a primary executor of validation activity. You have a willingness to perform "hands-on" work in a dynamic, fast-paced work setting.
- Execute validation activity as defined by approved protocols and test plans. Where applicable, this includes operating equipment or executing the process which is being validated.
- Perform relevant testing or evaluation during validation and document the results into validation protocols.
- Create detailed and meticulous records during validation activity meeting GMP standards.
- Investigate and troubleshoot validation problems as they occur.
- Complete validation activity in coordination with other related groups (e.g., manufacturing, engineering, or testing labs).
- Understand and apply the understanding of FDA and Quality System Requirements in carrying out duties.
Basic Qualifications and Capabilities:
- A minimum of a bachelor’s degree in a relevant technical field is required (e.g., engineering, biology, chemistry, etc.).
- General knowledge of the pharmaceutical industry, in particular drugs or biologics.
- 2 year’s progressive experience in a manufacturing, quality, technical, or validation role at a pharmaceutical manufacturing / distribution facility, with at least 1 year of validation activity.
- Knowledge or experience with technical documentation such as P&ID, wiring diagrams, and schematics preferred.
- Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
- Experience with regulatory inspections is preferred.
- Experience in sterile parenteral manufacturing is preferred.
