Utilities Engineer (376)

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 Utilities Engineer will be responsible for leading the GMP Utilities systems design, fabrication, installation, and commissioning for a newly announced facility expansion that includes a dedicated high-speed cartridge filling line, significant utilities upgrade, dedicated formulation and processing suites, with Clean-In-Place (CIP) and Sanitize-In-Place (SIP) capabilities. Working closely with system owners and related stakeholders this role will lead the utilizes area capacity expansion. Serves as subject matter expert for all GMP Utilities: Water for Injection (WFI), Clean Steam (CS), Instrument and Cleaned Compressed air systems, and process gas generation and distribution.

In this dynamic role you will provide GMP utilities expertise to help us establish our Petersburg, VA facility requirements, specifically for the Affordable Insulin expansion. You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting. Incumbent provides technical expertise on GMP Utilities and ensures compliance with relevant standards.

Essential Duties and Responsibilities:

• Support design, installation, acceptance testing, training activities, etc., ensuring all facilities and utilities systems adhere to pharmaceutical industry regulations and standards.
• Troubleshoot and perform risk assessments for utility systems to ensure safe installation, operation, and maintenance of utility systems and equipment.
• Maintain comprehensive documentation of maintenance activities, compliance records, and equipment specifications.
• Coordinate with contractors, and vendors to meet project goals. Strong collaborative and influencing skills, and ability to work well in a cross-functional, matrixed environment.
• 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.
• Lead or participate in projects/changes for all the systems under his/her responsibility, including design and verification activities (IV/OV/PQ), as user representative for capital projects or delivery agent for local projects.
• Proven track record of being self-motivated and capable of working with cross-functional teams while remaining positive towards project challenges.
• Develop the proper documentation (URs, Specifications, test cases, etc.) to demonstrate that systems are properly installed, qualified, and started up and that they remain in a controlled state.
• Comply with and support departmental EHS plans; ensure systems comply with all Environmental, Health, and Safety policies and procedures, and be knowledgeable 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.
• Responsible for the reliability and cost-effectiveness of the site's assigned utilities and ancillary systems associated with the facility.
• Drive continuous improvement initiatives and local capital investment projects.
• Ability to think strategically and tactically (detail-oriented).
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.

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.