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

Job Description

Civica is searching for a Process Engineer with knowledge in pharmaceutical drug product manufacturing, specifically in the areas of sterile injectable product formulation and filling, barrier system technology, and single-use fluid path components. The Civica Petersburg facility, nearing substantially complete construction, will be the first generic drug product facility in the US to use all isolator-style high-speed filling lines. During the project phase, you will primarily manage OEMs and engineering services providers through commissioning, qualification, and validation; and lead process development for two recently installed high-speed filling lines, and one future line dedicated to Civica Affordable Insulin <civicainsulin.org>. During the operational phase, you will be System Owner/SME of a high-speed filling line, optimizing equipment uptime and process robustness as we continue to transfer products currently produced by contract manufacturing sites, fulfilling Civica’s mission to “Do what’s in the best interest of patients.”

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

• Support execution of the Commissioning, Qualification, and Validation activities for our new Vial Filling system (e.g. washing/depyrogenation, aseptic filling, isolator/VPHP, glove integrity testers, environmental monitoring systems) including SAT, IQ/OQ, PQ, and Aseptic Process Simulation.
• Management of Equipment Vendors including project execution, on-site maintenance and calibration visits, vendor-supplied training of operation and maintenance staff, management of continuous improvement projects, and spare parts criticality assessments.
• Responsible for delivering cycle development for the process including VPHP cycles for Isolator & transport systems, and preparation of required GMP documentation for filling process and recipes.
• Support establishment of electronic batch record system for filler and isolator setup, operation, and changeover.
• Support transition from project to sustaining manufacturing and ramp-up of production volumes in future by improving equipment reliability through Continuous Improvement and TPM processes.
• Coordinate technical deliverables within Aseptic Operations team to support successful process and product launches.
• Lead and participate in cross-functional groups to investigate and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA.
• Manage change in the Vial Filling and/or Nest Filling areas as per site change control procedures.
• Participate in regulatory inspections e.g. FDA, DEA inspections as a Subject Matter Expert (SME).

BASIC QUALIFICATIONS and CAPABILITIES

• Bachelor’s degree in engineering, Materials Science, Biology, or related discipline.
• Exposure to parenteral processing equipment and operations including formulation, filling, visual inspection, and packaging equipment.
• Front-line support of aseptic filling equipment and/or barrier systems, e.g. isolator or RABS.
• Demonstrated ability to solve technical problems and implement projects.
• Excellent interpersonal and communication skills, and fluency in English.
• Strong Mechanical Aptitude.
• Minimum 3-5 years working in a cGMP environment, i.e. pharmaceutical, medical device, or food and beverage manufacturing.
• Ability to manage teams of varying education levels and cultural backgrounds to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Willingness to adapt to changing priorities as project demands change.
• Ability to explain complex technical issues to external customers / agencies.

PREFERRED QUALIFICATIONS

• SME-level knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
• Expertise in single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Demonstrated management and delivery of large capital projects ($1MM +).
• Experience with greenfield facility Commissioning, Qualification, and Validation (CQV) and production startup desired.