Process Engineer - Filling Operations (963)

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 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 . 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.