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Process Engineer

2 months ago

Washington, Washington, D.C., United States Civica Rx Full time

About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization established to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to do what's in the best interest of patients.

We are searching for a highly skilled Process Engineer to join our team at our state-of-the-art facility in Petersburg, VA. As a Process Engineer, you will play a critical role in the development and implementation of processes for the manufacture of sterile injectable products.

Key Responsibilities:

  • Manage OEMs and engineering services providers through commissioning, qualification, and validation
  • Lead process development for high-speed filling lines, including formulation, filling, visual inspection, and packaging equipment
  • Optimize equipment uptime and process robustness to ensure high-quality products
  • Collaborate with cross-functional teams, including Manufacturing, Automation, Quality Assurance, and R&D
  • Execute on-the-floor activities such as FAT, SAT, IQ/OQ, and Engineering batches

Requirements:

  • Bachelor's degree in engineering, Materials Science, Biology, or related discipline
  • Minimum 4+ years working in a cGMP environment, i.e. pharmaceutical, medical device, or food and beverage manufacturing
  • Experience with parenteral processing equipment and operations, including formulation, filling, visual inspection, and packaging equipment
  • Front-line support of aseptic filling equipment and/or barrier systems, e.g. isolator or RABS
  • Demonstrated ability to solve technical problems and implement projects
  • Excellent interpersonal and communication skills across various levels of the organization
  • Strong Mechanical Aptitude

Preferred Qualifications:

  • SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS)
  • Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications
  • Demonstrated management and delivery of large capital projects ($1MM +)
  • Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired