Packaging Engineer
3 weeks ago
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
Position Summary
The Packaging Engineer's primary responsibilities are to create packaging component specifications, BOMs, and complete the required testing to support Civica's manufacturing facilities, along with supporting the Packaging Process Engineers, PLD business, and CivicaScript as required. The successful candidate will routinely interface with outside vendors, Manufacturing, Quality, Engineering, and Supply Chain.
Essential Duties and Responsibilities
Create specifications for primary, secondary, and tertiary packaging components. Create bill of materials to define packaging configurations for each product. Write SOPs to define procedures for areas of responsibility. Coordinate ISTA/ASTM test procedures for packaging components and configurations. Write technical documents such as engineering standards, DOEs, and risk assessments. Assist with equipment project deliverables from URS through SAT including inspection, combination product assembly, and packaging equipment. 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 areas of responsibility as per change control procedures.Minimum Qualifications (Knowledge, Skills, and Abilities) Exposure to parenteral packaging 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. 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 cross-functional teams to execute activities. 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. Demonstrated excellence in planning and organizational skills.-
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