Validation Engineer - Insulin (377)
Civica

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-/)

Job Description:

The validation engineer will be responsible for leading the commissioning, qualification, and validation (CQV) for a newly announced facility expansion for biologics that includes a dedicated high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. Working closely with system owners and related stakeholders (operations, engineering, laboratories, IT, and quality assurance) this role will guide CQV activities to a compliant state throughout their lifecycle. This includes authoring, review, and execution of related CQV documentation as well as related documents for the role (e.g., procedures and change control records). Serves as subject matter expert for CQV activities.

Essential Duties and Responsibilities:

• 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, specifically the Affordable Insulin program.
• You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting. Incumbent provides technical expertise on CQV and ensure compliance to relevant standards.
• Responsible for CQV activity, including all phases: requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
• 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.

Basic Qualifications and Capabilities:

• Bachelor's degree in engineering or relevant sciences and 7+ years of CQV experience.
• 5 years' experience with sterile injectables, combo-devices, or biologics.
• Start-up experience preferred.
• Advanced degrees or certification relevant to the role is a plus.
• Ability to think strategically and tactically (detail-oriented).
• Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.

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