Manufacturing Tech II (439) - 3rd shift - Civica Rx

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 and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at  www.civicarx.org

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.

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. 
• Overtime, weekends and schedule adjustments may be required. 

3rd Shift - 11:00pm to 7:30am