Manufacturing Specialist - Line Lead 3rd Shift

About Civica

Over the past two decades, shortages of generic injectable medications have become commonplace and reached an all‑time high, with more than 300 essential medications reported in shortage by industry and FDA reports. "Race to the bottom" pricing, manufacturing challenges and predatory pricing are both causes and results. The patients suffer the most. Civica, a 501(c)(4) social welfare organization established in 2018 by leading health‑system foundations and philanthropies, works to reduce chronic generic drug shortages and high prices.

Over 55 health systems and 1,500 hospitals, plus federal agencies such as the VA, DoD and the Strategic National Stockpile, have joined our network. We also launched CivicaScript to lower pharmaceutical costs in retail pharmacies and are developing affordable biosimilar insulin in both vials and pre‑filled pens. Learn more icarx.org.

The Manufacturing Specialist Line Lead 3rd shift will play a part in the facility start‑up at the Civica Petersburg, VA site. Primary responsibilities focus on leading daily manufacturing activities, performing routine equipment, production and line activities, and ensuring timely pharmaceutical production. The role collaborates with stakeholders to support manufacturing execution, new product introductions, equipment qualifications, investigations, training and development.

• Lead the day‑to‑day production activities on the line, aligning and scheduling personnel and resources to meet daily and weekly production and equipment demands.
• Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross‑functional teams to meet production needs.
• Support onboarding and technical training of Manufacturing Operators on process equipment, including high‑speed fill lines with integrated isolators, terminal sterilizers, ATEC commodities processing, parts washers, autoclaves, single‑use technology and aseptic process simulations (media fills).
• Assist R&D and MSAT on new product introduction and tech transfer activities to ensure a steady stream of products to meet commercial demand.
• Initiate and complete manufacturing investigations, including root cause analysis and product impact assessment.
• Assist in the revision and management of manufacturing documents such as batch records and SOPs.
• Provide technical expertise and support to production teams, addressing issues and challenges while working closely with engineering and other support teams.
• Support regulatory inspections.
• Adapt and adjust priorities quickly in response to changes in the production schedule due to unforeseen disruptions, minimizing operational impact.

• A minimum of four+ years of experience in biopharmaceutical manufacturing in a GMP environment.
• An Associate’s degree or higher in Pharmaceutical Sciences, Biology, or a related field (preferred).
• Experience with sterile fill‑finish manufacturing.
• Knowledge of GMP, regulatory requirements and industry best practices.
• Detail‑oriented with a focus on accuracy in creating and updating production documents.
• Ability to work autonomously within established guidelines, procedures and practices.
• Experience in a process improvement environment, including change management.
• Experience using ERP systems.
• Strong communication and collaboration skills, committed to high‑quality standards.
• Experience as a shift lead, training others and developing training material.

• 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.
• Proficiency in Microsoft Office Suite.