Process Engineer, Biologics

Job Description

About Civica:

In the last two decades, the U.S. has faced a significant rise in shortages of essential generic injectable medications, with over 300 reported shortages. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing, ultimately impacting patients the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to alleviate chronic drug shortages and high prices. With over 55 health systems representing 1,500 hospitals, Civica also supplies essential medicines to the U.S. Department of Veterans Affairs and the Department of Defense. The organization prioritizes patient interests and has expanded its mission to include affordable medications at retail pharmacies through its sister organization, CivicaScript.

Recently, Civica announced plans to produce affordable biosimilar insulin, ensuring consistent availability for those in need. Long- and short-acting insulins will be priced at no more than $30 per vial and $55 for a pack of five pens. Learn more at www.civicarx.org.

Job Description:

The Process Engineer, Biologics will be essential in preparing the Civica Petersburg, VA facility for production and overseeing facility design for a new biologics expansion. This includes a high-speed cartridge filling line and dedicated processing suites. Reporting to the Director of Engineering, Insulin, you will collaborate with various teams to develop and improve technical transfer processes.

During the project delivery phase (ongoing through 2025), the Process Engineer will support startup activities, develop necessary systems for GMP operations, and foster site culture. Responsibilities include acting as System Owner for multiple manufacturing systems, ensuring compliance, and collaborating with Validation, Manufacturing, and Quality Assurance.

Essential Duties and Responsibilities:

• Engage in hands-on work in a team-oriented environment.
• Provide technical expertise on CQV activities and ensure compliance with regulations.
• Develop manufacturing processes and scale-up studies.
• Support all CQV activities for assigned systems.
• Execute Engineering deliverables promptly and proactively.
• Identify operational gaps and lead cross-functional groups for continuous improvement.
• Manage interactions across various business functions and with external vendors.
• Build control strategy documents and provide technical support to manufacturing teams.

Basic Qualifications and Capabilities:

• Bachelor’s degree in Pharmaceutical Sciences, Engineering, or a related field.
• Minimum of 3 years of relevant industry experience, preferably in Sterile Fill Finish or biologics.
• Familiarity with scale-up factors and FDA regulations.
• Strong problem-solving and communication skills.
• Ability to manage multiple complex assignments in a fast-paced environment.
• Willingness to adapt to changing project demands.

Preferred:

• 3+ years in sterile injectables or biologics.
• Expertise in drug product and material handling.
• Experience with capital equipment ordering and maintenance services.
• Familiarity with cleaning and process validation.
• Previous experience in greenfield sites or facility expansions.