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Process Engineer II
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 ensure that patients have access to essential medications at affordable prices.
Job Description:Process Engineer IIThe Process Engineer II will play a critical role in bringing our Petersburg, VA facility into a production-ready state and in facility and equipment design through commercialization for a newly announced facility expansion for biologics. This position will collaborate with Research & Development, Manufacturing Sciences & Technology (MSAT), Manufacturing, and Quality to develop, transfer, execute, and improve technical transfer processes to meet project and business objectives.
Key Responsibilities:- Develop and institute technical and procedural controls in the process design, considering scale up factors, calculations, and designing scale up / engineering batches to optimize manufacturing process to support exhibit batches.
- Support all CQV activity for assigned systems, including all phases: identifying user requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
- Execute Engineering deliverables in a timely manner, planning and proactively pursuing details and elevating risks appropriately to ensure project completion without avoidable delays.
- Anticipate operational gaps (improvements to facility/equipment design, process inefficiencies, job hazards) rather than scrambling to fix issues in the project startup, leading to a smoother and safer transition to the Manufacturing team.
- 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.
- Bachelor of Science Pharmaceutical Sciences, Engineering, or a similar technical degree. A post graduate degree is desired, but not required.
- Strong mechanical aptitude with a minimum of 6 years related industry experience preferably in Sterile Fill Finish, biologics, and material handling.
- Familiar with Scale up factors and design of process scale up studies and Experience working in FDA regulated environment.
- Demonstrated ability to solve technical problems and implement projects.
- Excellent interpersonal and communication skills, and fluency in English.
- 6+ years of experience in sterile injectables, drug-device combination products, or biologics.
- SME-level knowledge of drug product and material handling.
- Direct experience ordering capital equipment, materials required for production, spare parts, and calibration and maintenance services.
- Familiarity with cleaning validation and/or process validation.
