Manufacturing Tech II - 2nd shift at Civica Rx

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 #1 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. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Position Summary

Advanced level Manufacturing Technician position with the responsibility to weigh and dispense active pharmaceutical ingredients (API) and excipients in preparation of compounding. Compound bulk solutions for the filling operations and operate packaging equipment.

2nd Shift - 3:00 - 11:30 pm

Essential Duties and Responsibilities Under the Manufacturing Lead and/or Supervisor's direction, support manufacturing operations to meet strategic department objectives.

• Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas.
• Replenish manufacturing components, materials, and supplies in all processing areas.
• Transport bright stock and finished product to and from staging as required according to manufacturing schedule.
• Perform equipment cleaning and preparation for sterilization.
• Operate sterilizer equipment to provide format parts for filling equipment. Clean, set up, and decontaminate material transfer isolator.
• Clean, set up, and operate component processing equipment and terminal sterilizer equipment.
• Clean, set up, and operate weighing and compounding equipment.
• Weigh APIs and excipients according to batch record instructions.
• Compound bulk drug product per standard operating procedures and batch record instructions.
• Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices.
• Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
• Perform other duties as assigned by manufacturing management.
• Overtime and weekend work may be required at times.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• High school diploma or equivalent Coursework or bachelor's degree in a Life Science discipline preferred.
• 2-3 years' Experience in a pharmaceutical or cGMP regulated environment.
• High school graduate, vocational school graduate or equivalent
• Working knowledge of Microsoft applications and SAP
• Prior production experience
• Experience working in a LEAN manufacturing environment.
• Knowledge of cGMPs and FDA policies/procedures.

Preferred skills:

• Mechanical troubleshooting (manufacturing equipment)
• Aseptic Cleaning
• Equipment change part cleaning and sterilization
• Component/commodity sterilization
• Aseptic gowning/technique
• Good documentation practices
• Good reading and writing skills, and ability to perform basic to advanced mathematical calculations.
• Ability to read, understand and follow written procedures.