Quality Engineer II - Combination Products (930)

Job Details
About Civica:
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.
Shortages put patients at risk and waste hospital resources.
Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile with essential medicines. Civica currently supplies medicines to health system members in 49 states.
Civica's mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.
Civica's new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.
The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica's work to manufacture and distribute affordable medications. The Foundation's first commitment is to support Civica's efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.
Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.
Join us. Learn more at
Job Description
Responsibilities of the position include working across functions to provide hands-on Quality oversight and Quality Engineering input to develop maintain drug delivery device/ combination products for small and large molecules.
Responsibilities of the position include supporting quality management systems and oversight to ensure the product process validation, equipment qualification, and Quality Risk Management meet cGMP and Civica compliance requirements leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
The position is an onsite role at Civica Petersburg, Virginia facility.
Essential Duties and Responsibilities:

• Working across functions, to ensure and provide Quality oversight of the establishment and maintenance of Civica's quality systems related to pre-filled injectable syringe and pen combination products.
• Work with cross functional teams to provide Quality oversight for validation and qualification activities and ensure work for developed drug delivery device/ combination products for small and large molecules is performed in a compliant and controlled manner.
• Support evaluation and validation of packaging solutions.
• Partner with the medical device development team to ensure all elements of the design history file are executed and maintained.
• Ensure Product Development and Design