Aseptic Filling Process Engineer
Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company created by hospital systems and philanthropies, Civica’s mission is to reduce and prevent drug shortages while assuring quality generic medicines are accessible and affordable to everyone.
Because the United States experiences chronic shortages of essential generic medicines used daily in hospitals, we are building a state-of-the-art sterile injectable manufacturing facility to combat these shortages. This new facility is part of our broad strategy to stabilize the supply of generic medicines for emergency rooms, surgeries, COVID-19 patient care, and an array of other serious conditions.
WHO CIVICA SERVES
While serving 50 health systems and 1,350 hospitals (or 30% of all licensed U.S. hospital beds), Civica also supplies the U.S. Department of Veterans Affairs, the U.S. Department of Defense, and “340B” hospitals caring for vulnerable patients in some of the country’s most underserved areas. And recently, Civica contributed more than 2-million vials of essential medications to the strategic national stockpile.
With 40 sterile injectable medications under contract to supply our member hospitals, Civica is growing and on track to have 100 drugs under contract by 2023.
As we continue to grow, we have many exciting opportunities for multiple types of roles and with opportunity to progress YOUR career.
We are looking for an Aseptic Filling Process Engineer to help us build our state of the art greenfield sterile fill facility in Petersburg, VA (just outside of Richmond). This position be an integral part of the creation of aseptic filling operations including all design, fabrication, installation and qualification activities interacting with Vendors, Manufacturing, Quality, Engineering, and Supply Chain.
- Management of Equipment Vendors including 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 new Vial Filling Equipment e.g. filler, isolator/VHP, glove testers, particle monitoring systems including FAT, SAT, IQ and OQ.
- Responsible for delivering cycle development for the process including VHP cycles for Isolator & transport systems and preparation of required GMP documentation for filling process and recipes.
- Coordinate technical deliverables within Filling to support successful process 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 change in the Vial & Syringe Filling area as per site change control procedures.
- Support establishment of electronic batch record system for the Filling process
- Lead/participate in Standard Work, 5S, TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings.
- Participate in regulatory inspections e.g. FDA, DEA inspections
- Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes
- Exposure to parenteral processing equipment and operations including formulation, filling, visual inspection, and packaging equipment.
- Exposure or Front-line support to aseptic filling lines.
- Demonstrated ability to solve technical problems and implement projects.
- Strong interpersonal and communication skills.
- Project management experience.
- Ability to work effectively with outside suppliers.
- Knowledge of C4I and LEAN methodologies.
- Excellent verbal and written communications skills.
- Strong problem-solving skills.
- Strong Mechanical Aptitude.
Education and Experience
- Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
- Minimum 3-5 years working in a cGMP environment.
- Preferred candidate will have extensive aseptic filling experience.
- Ability to manage teams to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
- Ability to adapt to changing priorities as project demands change.
- CQV experience and experience with facility start up advantageous.
- Ability to explain complex technical issues to external customers / agencies.
- Demonstrated excellence in planning and organizational skills.
Salary DOE. Excellent Benefits