Manufacturing Specialist II – Nested Line (508) 2nd shift

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 and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the 1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs. More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications. Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens. Learn more about Civica’s plans and progress at www.civicarx.org Job Description 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 2 nd shift 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. Essential Duties and Responsibilities: Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs. 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. Initiate and complete manufacturing investigations including root cause analysis and product impact assessment. Drive the creation, revision, and management of manufacturing documents such as Batch Records and SOPs. Lead efficient GMP document and record reviews to minimize routing time. Provide technical expertise and support to production teams, addressing issues and challenges as they arise. Supports regulatory inspections as an SME for the area. 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. Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration. Develop and track KPI metrics to identify opportunities, failure points, and trending models Flex schedule to work outside routine 2nd shift hours at times to accommodate activities as needed. Basic Qualifications and Capabilities: Associate degree with 6 years demonstrated ability in a cGMP production environment. High School degree with 8 years of experience of cGMP production experience may be considered. Experience with sterile fill finish manufacturing. Detailed-oriented with a focus on accuracy in creating and updating production documents. Knowledge of GMP, regulatory requirements, and industry best practices. Proficiency in Microsoft Office suite. Strong communication and collaboration skills, with a commitment to meeting high-quality standards. Must be able to complete eye exam and have the visual ability to detect defects. Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment. Basic math skills to perform required calculations (multiplication/division), Good deviation and investigation writing skills. Ability to work autonomously and within established guidelines, procedures, and practices. Preferred Qualifications: Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS). Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications. Equipment qualification experience. Experience in using ERP systems. Position ID: 508 Shift: 3:00 pm – 11:30 pm. Monday through Friday.