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 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 have specific responsibility in the final project phase of construction at our new site and after project start-up for site day-to-day operation.
This role will be responsible for reliable and cost-effective operation of the site's HVAC, Utilities, and ancillary systems associated with our new manufacturing facility in Petersburg, VA. It will be essential to maintain all these systems in a state of compliance, safety, control, and fit for use. This role will also drive continuous improvement initiatives and local capital investment.
Major Accountabilities
- SME with a deep technical expertise in all systems under his/her responsibility (GMP HVAC, GMP Utilities and ancillary systems associated within their facilities), understanding their applications in pharmaceutical manufacturing, well versed with flow charts and process parameters, and awareness of industry trends.
- Ensure the assigned processes are in alignment with the applicable regulatory Industry and Civica Standards.
- Support risk assessment exercises using the different tools available (eg.FMEA) and participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals.
- Lead or participate in projects/changes for all the systems under his/her responsibility including design, verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
- Develop the proper documentation (URs, Specification, test cases, etc..) to demonstrate that systems are properly installed, qualified and started up and that remains in a controlled state.
- Monitor utility systems and maintain KPI's to assure that they are operating properly, in compliance with requirements.
- Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters.
- Implement efficient and effective maintenance and reliability techniques.
- Apply problem solving skills by leading equipment failures, troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues.
- Provide customer consultation and notifications on issues that involve utilities areas. Assure that all necessary items are identified on the proper tracking systems, and make sure that items are completed by the required date.
- Provide technical assistance as necessary to maintenance, and operations personnel.
- Support internal and external inspections and investigations (including Quality and HSE).
- Maintain efficient communications with appropriate site customer groups.
- Proficiency with the DMS and CAPA systems.
- Maintain, develop, and conduct operations training of utility systems.
- Utilize statistical analysis tools to determine the process control, and capability for investigations.
- Participate in Process Hazard Review meetings and/or Safety Teams as required by leadership
Education/Experience
- Bachelor’s degree in engineering or relevant sciences and 6+ years of experience with GMP Utilities
- 5 years’ experience with sterile injectables, combo-devices, or biologics.
- Start-up experience preferred.
- Advanced degrees or certification relevant to the role is a plus.
- Ability to think strategically and tactically (detail-oriented).
- Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.
- Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
- Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.
