Process Engineer, Biologics

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 Process Engineer, Biologics will play a critical role in bringing the Civica Petersburg, VA facility into a production-ready state and in facility and equipment design through commercialization for a newly announced facility expansion for biologics. Scope for the expansion includes a dedicated high-speed cartridge filling line, cartridge identification labeling, substantial upgrade to critical utilities services, and dedicated formulation and processing suites with Clean In Place (CIP) and Sanitize In Place (SIP) capabilities. Reporting to the Director of Engineering, Insulin you will extensively collaborate with Research & Development, Manufacturing Sciences & Technology (MSAT), Manufacturing, and Quality to: develop, transfer, execute, and improve technical transfer processes to meet project and business objectives.

In the project delivery and startup phase of the project (currently in progress through 2025), the responsibilities of the Process Engineer, Biologics 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 a full-scale GMP manufacturing through start-up.

The Process Engineer, Biologics, will act as a bridge between the project planning phase and ongoing operations by assuming System Owner responsibility for multiple manufacturing systems, with priority towards support activities and secondary packaging. Equipment areas of ownership include material transfer to and from automated visual inspection (AVI), collaborating with AVI system owners, laser printing on filled cartridges, and accumulation of pre-filled syringes, and cartridges for device assembly. In this role, the successful candidate will work closely with Validation, Manufacturing, and Quality Assurance to ensure availability, support, and maintenance of those system(s) throughout their lifecycle, and serve as subject matter expert internally and in regulatory inspections for production processes utilizing those systems.

Essential Duties and Responsibilities:

• You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting.
• Provide technical expertise on CQV activities and ensure compliance with regulatory requirements, industry best practices, and Engineering standards.
• Participate directly in the Engineering process to develop and institute technical and procedural controls in the process design. Responsible for developing the manufacturing process, considering scale-up factors and calculations, and designing scale-up / engineering batches to optimize the manufacturing process to support exhibit batches.
• Support all CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
• Anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.
• Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Interpersonal skills to manage interactions and drive results across a range of business functions, education levels, and cultural backgrounds within the site. Extends to external communication with system vendors.
• Build control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation.
• Provide technical support to manufacturing teams at various stages of operations starting from compounding, filtrations, fill and Finish, Terminal sterilization, Autoclave processes. Trouble shoot, resolve any technical issues, problems happen on the manufacturing floor.

Basic Qualifications and Capabilities:

• Bachelor of Science Pharmaceutical Sciences, Engineering, or a similar technical degree.
• Strong mechanical aptitude with a minimum of 3 years related industry experience preferably in Sterile Fill Finish, biologics, and material handling.
• Familiar with Scale up factors and design of process scale up studies and Experience working in FDA regulated environment.
• Demonstrated ability to solve technical problems and implement projects.
• Excellent interpersonal and communication skills, and fluency in English.
• Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment.
• Interact well with other functions (e.g. Manufacturing, Automation, Quality Assurance, R&D) and must be able to take ownership of and follow through on assigned projects with minimal required direction from his/her supervisor.
• Willingness to adapt to changing priorities as project demands change.

Preferred:

• 3+ years of experience in sterile injectables, drug-device combination products, or biologics.
• SME-level knowledge of drug product and material handling.
• Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
• Familiarity with cleaning validation and/or process validation.
• Previous work at greenfield sites or substantial facility expansion projects.