<b>About Civica:</b><br><br>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.<br><br>Shortages put patients at risk and waste hospital resources.<br><br>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.<br><br>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.<br><br>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.<br><br>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. <br><br>Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.<br><br>Join us. Learn more at <b>www.civicarx.org</b><br><br><strong>Job Description</strong><br><br>The Manufacturing Specialist II will play a key part in the facility start up with primary responsibilities focused around supporting daily manufacturing operations on the nested line and the timely production of pharmaceuticals at the Civica Petersburg, VA site. This key position will support manufacturing production execution, running equipment, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a face-paced manufacturing environment.<br><br><strong>Essential Duties and Responsibilities:</strong><br><ul><li>Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs.</li><li>Support onboarding and provide technical training of Manufacturing Operators on process equipment including Fillers with integrated Isolators, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.</li><li>Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.</li><li>Drive the creation, revision, and management of manufacturing documents such as Batch Records and SOPs.</li><li>Lead efficient GMP document and record reviews to minimize routing time.</li><li>Provide technical expertise and support to production teams, addressing issues and challenges as they arise.</li><li>Supports regulatory inspections as an SME for the area.</li><li>Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.</li><li>Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration.</li><li>Develop and track KPI metrics to identify opportunities, failure points, and trending models</li></ul><strong>Basic Qualifications and Capabilities:</strong><br><ul><li>Associate degree with 6+ years demonstrated ability in a cGMP production environment.</li><li>High School degree with 8+ years of experience of cGMP production experience may be considered.</li><li>Experience with sterile fill finish manufacturing.</li><li>Detailed-oriented with a focus on accuracy in creating and updating production documents.</li><li>Knowledge of GMP, regulatory requirements, and industry best practices.</li><li>Proficiency in Microsoft Office suite.</li><li>Strong communication and collaboration skills, with a commitment to meeting high-quality standards.</li><li>Must be able to complete eye exam and have the visual ability to detect defects.</li><li>Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.</li><li>Basic math skills to perform required calculations (multiplication/division),</li><li>Good deviation and investigation writing skills.</li><li>Ability to work autonomously and within established guidelines, procedures, and practices.</li></ul><strong>Preferred Qualifications:</strong><br><ul><li>Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).</li><li>Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.</li><li>Equipment qualification experience.</li><li>Experience in using ERP systems.</li></ul><strong>Position ID: </strong>339<br><br><strong>Shift:</strong> Flex schedule to work 1st or 2nd shift hours. Monday through Friday.