Principal Engineer Utilities & HVAC

About Civica

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.

Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Intro to Civica

https://vimeo.com/646267406

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 project phase of construction of the new site and after project completion during site day-to day operation.

During the project phase the Principal Engineer: Utilities & HVAC will be a key player in the cross functional project team in charge of the construction, commissioning, qualification, start-up and operational readiness of all site utilities and HVAC systems.

During the day-to-day operation, this role will be responsible for responsibly, reliably and cost effectively operating the site's HVAC, Utilities, and ancillary systems associated within their facility. It will be critical to maintaining 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

General

• Be the 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 Industry and Civica Standards
• Support risk assessment exercises using the different tools available (eg.FMEA)
• Participate as required in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals.
• Initial project asset delivery phase and future local capital investment.
• 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.
• Contribute to the process resource assessment, capital plans, expense budgets, and prioritize appropriate.
• 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 assigned.
• 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.
• Capable of data mining, data analysis, process monitoring, and lead process control tuning parameters.
• Assure that there is adequate site generation and distribution capacity by monitoring the site usage and staying abreast of future site requirements. This includes providing information for the site utilities master plan and reviewing the information provided by the customers as to their current and future demands.
• Consult on technical issues with operators, responsible engineers, and crafts.
• Maintain, develop, and conduct operations training of utility systems.
• Utilize statistical analysis tools to determine the process control, and capability for investigations.
• Comply with and support departmental EHS plans; ensure systems comply with all Environmental, Health and Safety policies and procedures, and be knowledge of Process Safety Management processes. (i.e., PSSR, GIPSM, CPH, etc.)
• Technical resource during process hazard reviews, establishing key EHS programs and policies.
• Participate in Process Hazard Review meetings and/or Safety Teams as required by leadership

Education Requirements

• Bachelor's degree in Engineering (prefer ME, EE, Chem E) (or equivalent work experience)
• Technical understanding of HVAC and Utilities
• Demonstrated office software skills (Word, Excel, PowerPoint, Outlook, UMS, data historian) and collaboration sites
• Excellent interpersonal, written and verbal communication skills
• Knowledge of regulated industry and working experiences with cGMP
• Demonstrated high level of understanding of engineering concepts, 1st principles, and engineering functional standards
• Strong technical aptitude and ability to train and mentor others
  Preferred Attributes But Not Required
• Previous start up experience
• Engineering experience in the pharmaceutical industry
• Previous equipment commissioning experience
• Engineering experience with manufacturing plant utilities
• Project management experience
• Experience with maintenance and computerized maintenance management systems (CMMS)
• Previous experience with deviation and change management systems preferred

PI196569529