Process Engineer II
4 days ago
About Civica Rx:
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. With a team of experienced health care and pharmaceutical industry leaders, Civica Rx has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter.
The Process Engineer II will play a critical role in bringing the Civica 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 role will involve collaborating 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.
- 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.
Requirements:
- Bachelor of Science in Pharmaceutical Sciences, Engineering, or a similar technical degree.
- 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.
About the Role:
This is an exciting opportunity to join a dynamic team at Civica Rx and contribute to the development of a new facility and the expansion of biologics manufacturing. The successful candidate will have a strong background in process engineering, excellent communication skills, and the ability to work collaboratively in a fast-paced environment.
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