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Process Engineer, Pharmaceutical

Company: Civica Rx
Location: Petersburg
Posted on: January 16, 2022

Job Description:

About Civica
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.
Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica's innovative model is directly impacting patient care, to read a recent article from the New England Journal of Medicine.
Intro to Civica
Position Summary
This Process Engineer is an integral part of the creation of aseptic filling and supporting operations at Civica's first manufacturing facility in Petersburg, Virginia. Key duties include coordinating equipment vendor activities through design, fabrication, installation, and qualification; and serving as front-line technical support to Manufacturing. The successful candidate will routinely interface with outside vendors, Manufacturing, Quality, Engineering, and Supply Chain.
Essential Duties and Responsibilities

  • Management of equipment vendors including the execution of FAT & SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments.
  • Support execution of the Commissioning & Qualification activities for responsible equipment (e.g. filler, isolator/VHP, packaging equipment, component prep, critical utility systems) including FAT, Commissioning, SAT, IQ and OQ.
  • Responsible for delivering cycle development for relevant processes and preparation of required cGMP documentation for production operations.
  • Coordinate technical deliverables across all business functions to support successful processes and product launches.
  • Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
  • Manage changes for responsible equipment as per site change control procedures.
  • Participate in regulatory inspections (e.g. FDA, DEA audits).
  • Lead improvement of equipment reliability through CI and TPM processes to support the transition from project level to sustainable manufacturing/ramp up production.
    Minimum Qualifications (Knowledge, Skills, and Abilities)

    • Exposure to parenteral processing equipment and operations including formulation, filling, visual inspection, and packaging equipment preferred.
    • Strong interpersonal and communication skills, both written and verbal.
    • Project management experience.
    • Ability to work effectively with outside suppliers.
    • Knowledge of C4I and LEAN methodologies.
    • Strong problem-solving skills.
    • Strong mechanical aptitude and hands-on approach.
    • Familiarity with engineering and architectural/construction drawings highly advantageous.
    • Demonstrated ability and willingness to accept ownership of new technical challenges and assigned projects.
    • Passion for Civica's mission to provide affordable quality generic medicines that are accessible to all.

      Education and Experience

      • B.S. in Engineering or Science discipline required.
      • Experience working in a cGMP environment preferred.
      • Ability to manage teams to execute activities on the manufacturing floor.
      • Experience in data-driven approach to root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma, 5-why, fishbone diagram).
      • Ability to adapt to changing priorities as project demands and business needs change.
      • CQV experience and greenfield facility start up experience preferred.
      • Ability to explain complex technical issues to external customers/agencies.
      • Demonstrated excellence in planning and organizational skills.

        Physical Demands and Work Environment
        The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk and hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

Keywords: Civica Rx, Richmond , Process Engineer, Pharmaceutical, Engineering , Petersburg, Virginia

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