Process Engineer – Filling Operations

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 drugs currently reported as unavailable. This crisis stems from “race to the bottom” pricing, manufacturing challenges, and predatory pricing practices. Patients are the ones who suffer the most.

Civica, a 501(c)(4) social welfare organization founded in 2018 by various health systems and philanthropies, aims to combat chronic drug shortages and high prices. With over 55 health systems representing more than 1,500 hospitals, Civica has also supplied 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 reducing pharmacy costs through its sister organization, CivicaScript.

Recently, Civica announced plans to produce affordable biosimilar insulin, ensuring consistent access for those who struggle to afford this vital medication. Long- and short-acting insulins will be available at no more than $30 per vial and $55 for a pack of five pens. Learn more at www.civicarx.org.

Job Description

Civica is seeking a Process Engineer with expertise in pharmaceutical manufacturing, particularly in sterile injectable product formulation and filling. The Petersburg facility will be the first U.S. generic drug facility to utilize isolator-style high-speed filling lines. You will manage OEMs and engineering services during commissioning and lead process development for high-speed filling lines, including one dedicated to Civica Affordable Insulin. As System Owner/SME, you will optimize equipment uptime and process robustness, supporting Civica’s mission to prioritize patient welfare.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Oversee Commissioning, Qualification, and Validation for the new Vial Filling system.
• Manage Equipment Vendors for project execution and maintenance.
• Develop filling process cycles and prepare GMP documentation.
• Establish an electronic batch record system for operations.
• Support the transition to sustaining manufacturing and ramp-up production.
• Coordinate technical deliverables within the Aseptic Operations team.
• Lead cross-functional groups for technical issue resolution and process optimization.
• Manage changes in the Vial Filling area per site procedures.
• Participate in regulatory inspections as a Subject Matter Expert (SME).

BASIC QUALIFICATIONS and CAPABILITIES

• Bachelor’s degree in engineering or related field.
• Experience with parenteral processing equipment.
• Support for aseptic filling equipment and barrier systems.
• Proven problem-solving and project implementation skills.
• Strong communication skills and fluency in English.
• Minimum 3-5 years in a cGMP environment.
• Ability to manage diverse teams and adapt to changing priorities.
• Capability to explain complex technical issues to external stakeholders.

PREFERRED QUALIFICATIONS

• Expertise in high-speed aseptic filling and barrier systems.
• Knowledge of single-use components in drug formulation.
• Experience managing large capital projects.
• Familiarity with greenfield facility Commissioning, Qualification, and Validation.