Principal Engineer: Utilities and HVAC

Principal Engineer: Utilities and HVAC (920) Job Purpose The Principal Engineer: Utilities & HVAC is the site Subject Matter Expert (SME) for GMP HVAC and Critical Utility systems (WFI, Clean Steam, Process Compressed Air, and Nitrogen) and the ancillary support systems. This role will be responsible for reliable and cost‑effective operation of the site’s HVAC, utilities, and ancillary systems at the new manufacturing facility in Petersburg, VA. Maintaining all systems in compliance with regulatory and internal standards, driving continuous improvement initiatives, and managing local capital investment will also be key responsibilities. Company Overview Civica is a nonprofit organization established in 2018 to prevent and mitigate drug shortages. With nearly 60 health‑system members representing over 1,400 hospitals in 49 states, Civica supplies essential medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile. The company’s mission extends from hospitals to consumers through CivicaScript, which provides affordable outpatient generic medicines. Civica’s new 140,000 square‑foot manufacturing facility in Virginia will produce sterile injectables and affordable biosimilar insulin, ensuring widespread access to quality medications. Major Accountabilities Serve as SME with deep technical expertise in GMP HVAC, utilities, and ancillary systems, understanding their application in pharmaceutical manufacturing. Ensure assigned processes align with applicable regulatory industry and Civica standards. Participate in risk assessment exercises (e.g., FMEA) and support departmental, site, and company goals. Lead or participate in projects/changes for all systems, including design, verification activities (IV/OV/PQ), and local capital projects. Develop required documentation (URs, specifications, test cases, etc.) to demonstrate qualified and controlled systems. Monitor utility systems and maintain KPIs to assure proper operation and compliance. Provide written operational instructions and maintain equipment within controlled parameters. Implement effective maintenance and reliability techniques. Lead troubleshooting, conduct RCA, and guide operations personnel in resolving process issues. Offer customer consultation and notifications on utility‑related issues, ensuring timely completion of tracked items. Provide technical assistance to maintenance and operations personnel. Support internal and external inspections and investigations (including Quality and HSE). Maintain efficient communication with appropriate site customer groups. Use DMS and CAPA systems proficiently. Develop and conduct operations training for utility systems. Utilize statistical analysis tools to determine process control and capability during investigations. Participate in Process Hazard Review meetings and safety teams as required. Education/Experience Bachelor’s degree in engineering or relevant sciences and 6+ years of experience with GMP utilities. 5 years of experience with sterile injectables, combo‑devices, or biologics. Start‑up experience preferred. Advanced degrees or certifications relevant to the role are a plus. Strategic and tactical thinking skills with attention to detail. Strong collaboration and influencing skills, capable of working in a cross‑functional, matrixed environment. Ability to work in a fast‑paced team, meet deadlines, and prioritize work. Proven self‑motivation and ability to work with cross‑functional teams while remaining positive toward project challenges. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Engineering and Information Technology #J-18808-Ljbffr