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Aseptic Filling Process Engineer

Company: Civica Rx
Location: Petersburg
Posted on: November 26, 2022

Job Description:

About Civica 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. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third 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 recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica's innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. ( ) To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace. ( ) Essential Duties

  • Management of Equipment Vendors including 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 new Vial Filling Equipment e.g. filler, isolator/VHP, glove testers, particle monitoring systems including FAT, SAT, IQ and OQ.
  • Responsible for delivering cycle development for the process including VHP cycles for Isolator & transport systems and preparation of required GMP documentation for filling process and recipes.
  • Coordinate technical deliverables within Filling to support successful process 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 change in the Vial & Syringe Filling area as per site change control procedures.
  • Support establishment of electronic batch record system for the Filling process
  • Lead/participate in Standard Work, 5S, TPM, CI & Gemba programs and daily/weekly tiered manufacturing meetings.
  • Participate in regulatory inspections e.g. FDA, DEA inspections
  • Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes Required Skills
    • Exposure to parenteral processing equipment and operations including formulation, filling, visual inspection, and packaging equipment.
    • Exposure or Front-line support to aseptic filling lines.
    • Demonstrated ability to solve technical problems and implement projects.
    • Strong interpersonal and communication skills.
    • Project management experience.
    • Ability to work effectively with outside suppliers.
    • Knowledge of C4I and LEAN methodologies.
    • Excellent verbal and written communications skills.
    • Strong problem-solving skills.
    • Strong Mechanical Aptitude. Education and Experience
      • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
      • Minimum 3-5 years working in a cGMP environment.
      • Preferred candidate will have extensive aseptic filling experience.
      • Ability to manage teams to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
      • Ability to adapt to changing priorities as project demands change.
      • CQV experience and experience with facility start up advantageous.
      • Ability to explain complex technical issues to external customers/agencies.
      • Demonstrated excellence in planning and organizational skills. Salary DOE. Excellent Benefits

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Keywords: Civica Rx, Richmond , Aseptic Filling Process Engineer, Engineering , Petersburg, Virginia

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