Computer System Validation Engineer

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. (To learn more about Civica''s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace. (Intro to Civica Job Summary The Computer System Validation Engineer will be responsible to develop and execute validation projects related to GXP computer systems, software, automation, and data integrity. Working closely with system owners and related stakeholders (operations, engineering, laboratories, IT, and quality assurance) this role will guide systems to a compliant state throughout their lifecycle. This includes authoring, review, and execution of related validation documentation as well as related documents for the role (e.g., procedures and change control records). Serves as subject matter expert for CSV activity. Major Accountabilities We are seeking a highly motivated Validation Engineer who is interested in joining our fast-paced, dynamic start-up environment. In this dynamic role you will provide validation expertise to help us establish our Petersburg, VA facility. You must have a willingness to perform ''hands-on'' work in a dynamic, team-oriented work setting. Incumbent provides technical expertise on CSV and ensure compliance to relevant standards. • Responsible for computer systems validation activity, including all phases: requirements, validation planning, protocol generation, test execution, configuration documentation, and system release. • Ensures quality of validation activity to ensure compliance to key standards including 21 CFR Parts 11 and 211. • Supports IT and business process owners or impacted systems to coordinate related activities such as purchase, installation, configuration, data migration, upgrade, decommission, procedure drafting, troubleshooting, and system auditing. • Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays. • Interpersonal skills to manage interactions and achieve results across a range of functions within the site. May also extend to external communication with system vendors.Relevant Skills / Experiences Experience in pharmaceuticals or cGMP environment, with a preference for injectable drug products. Experience in closely related fields such as medical devices or DEA may also be applicable. Experience in computer systems data integrity, including ALCOA principles. Minimum 3 years experience in validation, with a preference for experience directly tied to computer systems. Relevant IT skills - standard Microsoft Office tools are mandatory. Experience in Veeva, Deacom, or Empower are also preferred as software systems directly related to this role. Ability to think strategically and tactically (detail-oriented). Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment. Education (minimum/desirable) Bachelor''s degree from an accredited college/university (a degree in relevant sciences, engineering or medically related field is preferred). Advanced degrees or certification relevant to the role are desirable. PI187943686

Created: 2025-10-04