Process Engineer II
Job Description
About Civica
Civica is a 501(c)(4) social welfare organization founded in 2018 by health systems and philanthropies to tackle chronic generic drug shortages and high prices in the U.S. Led by a team of healthcare and pharmaceutical experts, Civica has over 55 health systems as members, representing more than 1,500 hospitals and one-third of U.S. hospital beds. The organization supplies essential medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile.
Recently, Civica announced CivicaScript, aimed at producing affordable insulins for diabetes patients, set to launch in 2024. This initiative will help those struggling to afford life-saving medications, especially the uninsured or underinsured.
Civica’s mission is to ensure access to quality generic medications for all, guided by the principle of “Do What Is in the Best Interest of Patients.” The Petersburg, Virginia manufacturing facility, currently under construction, will produce affordable insulin and essential sterile injectables.
To learn more about Civica’s impact on patient care, click here for a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)
For details on Civica’s plans for affordable insulin, click here for an article in BioSpace. (https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)
Job Description
The Process Engineer II will be essential in preparing the Civica Petersburg, VA facility for production and in designing equipment for a new biologics expansion. This includes a high-speed cartridge filling line and upgraded utilities.
During the project delivery and startup phase (ongoing through 2025), the Senior Process Engineer will support startup efforts, develop systems for GMP operations, and foster site culture. Collaboration and creativity will be key as the site transitions to full-scale GMP manufacturing.
The Senior Process Engineer will bridge project planning and operations, taking ownership of manufacturing systems and collaborating with Validation, Manufacturing, and Quality Assurance to ensure system lifecycle support and compliance.
Essential Duties and Responsibilities
- Willingness to perform hands-on work in a team-oriented environment.
- Provide technical expertise on CQV activities, ensuring compliance with regulations and standards.
- Participate in engineering processes to establish technical controls in design.
- Accountable for CQV activities, including validation planning and protocol execution.
- Execute engineering deliverables promptly, managing risks to avoid delays.
- Identify operational gaps to facilitate a smooth transition to manufacturing.
- Lead cross-functional teams to resolve technical issues and drive process improvements.
- Manage interactions across various business functions and communicate with system vendors.
Basic Qualifications and Capabilities
- Bachelor’s degree in Engineering required.
- Strong mechanical aptitude.
- Proven problem-solving skills and project implementation experience.
- Excellent communication skills and fluency in English.
- Self-directed with strong analytical skills, able to manage multiple assignments.
- Ability to collaborate with various functions and take ownership of projects.
- Adaptability to changing project demands.
Preferred
- 5+ years of experience in sterile injectables, drug-device combinations, or biologics.
- Expertise in drug product processing equipment.
- Experience in ordering capital equipment and production materials.
- Familiarity with cleaning and process validation.
- Previous experience with greenfield sites or facility expansions.