Process Engineer II, Automated Visual Inspection
Civica

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

Job Description

The Process Engineer II, Automated Visual Inspection, will function as an integral part of the creation of packaging operations at Civica's first manufacturing facility in Petersburg, Virginia. Key duties include coordinating equipment vendor activities through design, fabrication, installation, and qualification and serving as front-line technical support to Manufacturing. Responsible for vial, cartridge, and syringe automated visual inspection machines, including de-nesting and re-nesting systems. The successful candidate will routinely interface with outside vendors, Manufacturing, Quality, Engineering, Supply Chain, and Maintenance.

Essential Duties and Responsibilities:

The essential functions include, but are not limited to the following:

• Management of equipment vendors including the 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 responsible equipment including FAT, SAT, commissioning, IQ, OQ, and PQ.
• Responsible for drafting and executing engineering trials, DOEs, and preparation of required cGMP documentation for production operations.
• Draft risk assessments and specifications for defect kits to be utilized for equipment qualification.
• 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 responsible equipment as per site change control procedures.
• Participate in regulatory inspections (e.g. FDA, DEA audits).
• Lead improvement of equipment reliability through CI and TPM processes to support the transition from project level to sustainable manufacturing/ramp up production.
• Prepare and update Preventative Maintenance (PM) tasks relating to production equipment maintenance needs.
• Lead and participate in investigations related to the equipment.

• 6+ years of Process Engineering experience.
• 3 years of Automated Visual Inspection experience.
• B.S. in Engineering or Science discipline.
• Ability to manage teams to execute activities on the manufacturing floor.
• 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.
• Ability to explain complex technical issues to external customers/agencies.
• Demonstrated excellence in planning and organizational skills. Strong interpersonal and communication skills, both written and verbal.
• Project management experience.
• Ability to work effectively with outside suppliers.
• Knowledge of Lean/Six Sigma methodologies.
• Strong problem-solving skills.
• Strong mechanical aptitude and hands-on approach.
• Familiarity with engineering and architectural/construction drawings is highly advantageous.
• Demonstrated ability and willingness to accept ownership of new technical challenges and assigned projects.
• Passion for Civica's mission is to provide affordable quality generic medicines accessible to all.

• Experience working in a cGMP environment.
• 3 years of Automated Visual Inspection experience.
• CQV experience and greenfield facility start-up experience.