Engineering Specialist Operations

2 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 ensure that patients have access to essential medications at affordable prices.

Job Summary

The Engineering Specialist, Operations will play a critical role in the facility start-up at our Civica Petersburg, VA site. This position will support daily engineering operations and the timely production of pharmaceuticals. The ideal candidate will have a consistent track record of achieving results in a fast-paced manufacturing environment.

Key Responsibilities
  • Collaborate with cross-functional teams to meet production needs and ensure compliance with GMP regulations.
  • Support onboarding and technical training of Engineering personnel on Facilities, Utilities, Manufacturing, and Packaging equipment.
  • Investigate and resolve engineering-related issues, including data gathering, root cause analysis, and product impact assessment.
  • Develop and manage engineering documents, such as technical reports and SOPs.
  • Provide technical expertise and support to engineering teams, including Change Controls and CAPAs.
  • Support regulatory inspections and ensure compliance with industry best practices.
Requirements
  • Associate's degree in Pharmaceutical Sciences, Engineering, or a related field.
  • Minimum of four years' experience in Sterile Injectables, Biopharmaceutical, or Pharmaceutical manufacturing in a GMP environment.
  • Experience with sterile fill finish manufacturing and clean utilities.
  • Detailed-oriented with a focus on accuracy in creating and updating engineering documents.
  • Experience in using ERP systems and knowledge of GMP, regulatory requirements, and industry best practices.
  • Strong communication and collaboration skills, with a commitment to meeting high-quality standards.
Preferred Qualifications
  • Knowledge of clean utilities, plant utilities, metrology, high-speed pen assembly, high-speed aseptic filling, autoclaves, and isolators.


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