Process Engineer

3 days ago


US Petersburg VA USA Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing 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 a team of experienced healthcare and pharmaceutical industry leaders working together to make a difference. Our goal is to provide affordable and accessible medications to those who need them most.

Job Description

We are seeking a Process Engineer with experience in pharmaceutical drug product manufacturing, specifically in the areas of sterile injectable product formulation and filling, barrier system technology, and single-use fluid path components.

The successful candidate will be responsible for managing OEMs and engineering services providers through commissioning, qualification, and validation, and leading process development for high-speed filling lines. They will also be the System Owner/SME of a high-speed filling line, optimizing equipment uptime and process robustness.

Key Responsibilities
  • Manage OEMs and engineering services providers through commissioning, qualification, and validation
  • Lead process development for high-speed filling lines
  • Optimize equipment uptime and process robustness
  • Collaborate with cross-functional teams to ensure smooth project execution
Requirements
  • Bachelor's degree in engineering, materials science, biology, or related discipline
  • Minimum 4+ years working in a cGMP environment
  • Experience with parenteral processing equipment and operations
  • Front-line support of aseptic filling equipment and/or barrier systems
  • Demonstrated ability to solve technical problems and implement projects
Preferred Qualifications
  • SME-level knowledge of high-speed aseptic filling and barrier system technology
  • Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications
  • Demonstrated management and delivery of large capital projects

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