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
In this critical role, you will be responsible for supporting the site engineering function and ensuring it has the necessary capacity, capability, and leadership structures in place to deliver the site engineering deliverables in support of the manufacturing plan. The Senior Manager Maintenance & Utilities provides administrative and technical leadership for the site engineering function, including process engineering, process automation, maintenance, utilities, plant and project engineering, and engineering competencies. You must be able to manage multiple projects with frequent changes and be able to coordinate and manage project activities while involving cross-functional partners. Incumbent provides technical expertise on Maintenance, Reliability, Facilities, and Compliance standards and provides input on strategy to key business leaders.
As a subject matter expert for site utility systems and maintenance programs, you will ensure compliance and inspection readiness and provide cross-functional support to other departments. In the project delivery and startup phase of the project (startup currently in progress through 2025), the Senior Manager, Maintenance and Utilities will be dynamic as we endeavor to support the startup, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows to full-scale GMP manufacturing through start-up.
Essential Duties And Responsibilities
- The incumbent is accountable for the maintenance/management of the utilities area and personnel in alignment with the requirements company guidelines, local requirements and federal regulations. The area of responsibility covers all clean and plant utilities such as WFI, CCA, CA, Compress Gasses, Compressed Air, Chilled Water, Steam Generation systems, Waste Neutralization Skid, HVAC systems, Exhaust, Fire Protection systems and general plant electrical infrastructure and distribution and Maintenance Shop.
- Responsible and Oversees the Calibration and Maintenance & Repairs programs.
- Support the development and oversight of the site preventative maintenance program.
- Generates project execution plans, including procurement strategies for outside services and materials. Leads/assists with vendor selection and contract negotiations.
- Leads qualification tasks (plan, controlling and reporting) in coordination with the Engineering and Quality organizations according to valid SOP’s and issues plant documentation according to site engineering requirements.
- Provides technical expertise in the SME area, including training other team members and operations staff.
- Support the development and oversight of the site preventative maintenance program.
- Site services, including Landscaping, Facilities Maintenance, Housekeeping, Pest Control Services, Security, and Solid waste (Domestic Waste).
- Establish and maintain a spare part program.
- Establish departmental metrics.
- Establish and maintain a planning and scheduling program.
- Ensure compliance with all company policies and procedures, including safety and maintaining good housekeeping.
- Attract, develop, and retain a diverse, qualified staff through effective training, succession planning strategies, and ongoing performance feedback. Drive a culture of engagement and inclusivity throughout the organization through clear communication, collaboration, and recognition.
- Ensures compliance to all applicable business policies, laws and regulations, inclusive of U.S. Food and Drug Administration (FDA) regulations, Occupational Safety & Health Administration (OSHA) regulations, Good Manufacturing Practices (GMP’s) and other regulatory requirements, company policies, operating procedures, and processes. Interface with internal and external regulatory agencies and government officials.
- Ensure utilities are provided to site operations at all times.
- Analytical skills to identify potential improvement opportunities
- Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)
- Serve as a key member of the Engineering Safety Team, ensuring safety focus throughout project delivery and startup, establishing safety culture and demonstrating focus on safety through the identification and elimination of risk.
- Ensure that a robust control system exists to manage the business, identify compliance issues, and escalate issues appropriately is established and maintained.
- In collaboration with key business functions, innovate and develop maintenance & engineering solutions that deliver productivity, quality, and efficiencies that meet and exceed cost improvement targets.
Basic Qualifications And Capabilities
- A bachelor’s degree in engineering (Mechanical, Electrical, Industrial) or similar technical degree is required.
- 10+ years of progressive leadership experience in utilities and facilities or related roles in the pharmaceutical/FDA-regulated manufacturing environment.
- 7+ years of subject matter expertise with GMP Critical Utilities and Facilities.
- Working knowledge of CMMS and Metrology.
- Demonstrated knowledge of cGMPs and FDA requirements required.
- A solid working knowledge of facility/equipment validation requirements.
- Previous experience/best practices implementing and using continuous improvement/lean tools such as Kaizen, Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.
- Project management and time management experience, with the ability to partner and influence across a matrixed environment. Excellent communication skills, verbal & written.
Preferred Qualifications
- Previous operational readiness/project management and start-up experience.
- Previous experience in a Sterile Injectables facility.
- Demonstrated management and delivery of large capital projects.
- Knowledge and understanding of Data Integrity and how it applies to the BioTech Industry with specific focus on guidelines from the FDA.
- EIT or PE engineering license.
