Process Engineer II, Automated Visual Inspection (544)

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

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.

Basic Qualifications and Capabilities:

• 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.

Preferred Qualifications:

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