Packaging Engineer

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 

The Packaging Engineer’s primary responsibilities are to create packaging component specifications, BOMs, and complete the required testing to support Civica’s manufacturing facilities, PLD business, and CivicaScript. 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 FAT including inspection, device 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