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.
Civica is building a 100 million dollar state-of-the-art manufacturing plant. Join us to help serve patients!
The primary responsibility of the Process Engineer is to support Compounding and Equipment Prep operations including all design, fabrication, installation, and qualification activities interacting with Vendors, Manufacturing, Quality, Engineering, and Supply Chain.
- Management of Equipment Vendors through design, fabrication and execution of FAT & SAT, on-site start-up, maintenance, management of continuous improvement projects & spare parts criticality assessments.
- Support execution of the Commissioning & Qualification activities for Compounding and Process Support Equipment e.g. Single Use Mixers, Parts Washers, Autoclaves, Terminal Sterilizer, Component Processors, etc., including FAT, SAT, IOQ, through commercialization.
- Coordinate technical deliverables to support successful process and product launches.
- Able to respond to off-hour support calls to attend to troubleshooting and/or process decisions. Able to work within a Team Environment to drive result driven solutions.
- Performs process monitoring and data tracking and trending of key attributes to ensure process remains in-control.
- 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 Compounding & Support areas as per site change control procedures.
- Support establishment of electronic batch record system for the Compounding & Support processes
- Lead/participate in Standard Work, RCA, CI 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
Key Performance Indicators
- Exposure to parenteral processing equipment and operations including formulation, filling, visual inspection, and packaging equipment.
- Exposure or Front-line support to Compounding and Equipment Prep.
- Demonstrated ability to solve technical problems and implement projects.
- Strong interpersonal and communication skills.
- Project management experience.
- Ability to work effectively with outside suppliers.
- Excellent verbal and written communications skills.
- Strong problem-solving skills.
- Strong Mechanical Aptitude.
- 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 experience with equipment prep and compounding 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.
- Demonstrated skills in communication (oral and written) & with technical writing.
Salary DOE, excellent benefits.