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Process Engineer
2 months ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to do what's in the best interest of patients.
Job DescriptionWe are seeking a highly skilled Process Engineer to join our team at our Petersburg, VA facility. As a Process Engineer, you will be responsible for managing OEMs and engineering services providers through commissioning, qualification, and validation of our high-speed filling lines. You will also lead process development for our sterile injectable product formulation and filling operations.
Key Responsibilities:- Support execution of Commissioning, Qualification, and Validation activities for our new Vial Filling system.
- Manage Equipment Vendors, including project execution, on-site maintenance and calibration visits, and vendor-supplied training.
- Deliver cycle development for the process, including VPHP cycles for Isolator & transport systems, and preparation of required GMP documentation.
- Support establishment of electronic batch record system for filler and isolator setup, operation, and changeover.
- Transition from project to sustaining manufacturing and ramp-up of production volumes 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.
- 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.
- 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 +).
Civica Rx is an equal opportunity employer.
