Engineering Specialist Operations

4 weeks ago

Petersburg, Virginia, United States 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 team of healthcare and pharmaceutical industry leaders is committed to "Do What Is in the Best Interest of Patients."

We have expanded our mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. Our sister organization, CivicaScript, partners with Blue Cross Blue Shield entities and others to reduce select high-cost generic drugs where market forces are not working to control drug costs.

The Engineering Specialist, Operations will play a key role in the facility startup at our Civica Petersburg, VA site. This position will support daily engineering operations and the timely production of pharmaceuticals. In collaboration with stakeholders, the ideal candidate will support cross-functional teams with equipment qualifications, change management, investigations, SOP revisions, training, metrics, and development.

Key Responsibilities:

  • Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety, and other cross-functional teams to meet production needs.
  • Support onboarding and technical training of Engineering personnel on Facilities, Utilities, Manufacturing, and Packaging equipment.
  • Initiate and complete engineering-related investigations, including data gathering, reports, root cause analysis, product impact assessment, and leading cross-functional meetings with involved parties.
  • Assist in the creation, revision, and management of engineering documents, such as technical reports and SOPs.
  • Provide technical expertise and support to engineering teams by managing Change Controls and CAPAs.
  • Support regulatory inspections.
  • Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.

Basic Qualifications:

  • Associate's degree in Pharmaceutical Sciences, Engineering, or a related field preferred.
  • A minimum of four years' experience in Sterile Injectables, Biopharmaceutical, or Pharmaceutical manufacturing in a GMP environment.
  • Experience with sterile fill-finish manufacturing.
  • Detailed-oriented with a focus on accuracy in creating and updating engineering documents.
  • Experience in using ERP systems.
  • Knowledge of GMP, regulatory requirements, and industry best practices.
  • Strong communication and collaboration skills, with a commitment to meeting high-quality standards. Strong writing and documentation skills.
  • Experience in a process improvement environment, including change management, optimizing process flow, and participating in Lean/Six Sigma project teams.
  • Self-directed with effective analytical and problem-solving skills preferred.
  • Interact with other functions and must be able to take ownership of and follow through on assigned projects.

Preferred Qualifications:

  • Knowledge of clean utilities, plant utilities, metrology, high-speed pen assembly, high-speed aseptic filling, autoclaves, and isolators among others.

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