Location: Baltimore, MD
Join a premier global Contract Development and Manufacturing Organization (CDMO) that is rapidly expanding its state-of-the-art sterile manufacturing footprint in Baltimore. This organization is a strategic partner to leading pharmaceutical and biotech companies, specializing in the end-to-end development and commercialization of complex injectable products. With a reputation for scientific excellence and a commitment to Quality by Design, they offer a dynamic, client-facing environment where technical experts lead the transition of life-saving therapies from the lab to commercial scale.
The CSV Engineer will interact with QA, IT, and business area users to generate user requirements and understand system functionality and use with respect to computerized systems and data integrity. Maintain current system functionality and use to ensure cGMP regulatory compliance. Perform periodic reviews and remediation activities for validated systems.
In this role, you will be expected to organize and coordinate complex tasks, solving issues independently using sound judgment. You should be comfortable working in a fast-paced environment with frequent interruptions. The position requires strong visual acuity and eye/hand coordination for keyboard use and traversing laboratory areas. You will primarily work on-site with minimal travel, occasionally working around extreme temperatures or noise above conversation levels. Regular and predictable attendance is essential to support our laboratory operations.
CSV Engineer • Baltimore, MD, United States
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