CQV engineer
United Pharma Technologies Inc
Our client is a Contract Development and Manufacturing Organization (CDMO) seeking an experienced CQV Engineer to support ongoing projects. The candidate will work in a fast-paced qualification and validation environment, partnering closely with the client’s Qualification/Validation and IT teams to support validation protocol changes/revisions and the execution of validation protocols. The primary equipment and systems supported will include: Sartorius bioreactors/reactors ranging from 50L to 500L Cytiva chromatography skids Incubators TFF (Tangential Flow Filtration) systems Chromatography systems Sartorius MFCS data acquisition software used for collecting and storing equipment data in a compliant manner Key Responsibilities Support CQV and validation activities within a fast-paced CDMO environment. Review, revise, and update validation protocols based on project or system changes. Execute IQ/OQ/PQ protocols for pharmaceutical manufacturing and laboratory equipment. Prepare and complete Validation Summary Reports (VSRs) . Support qualification and validation of Sartorius bioreactors/reactors and Cytiva chromatography skids . Support validation activities for TFF/filtration systems, incubators, and chromatography equipment . Work with Siemens Desigo environmental control systems. Support Sartorius MFCS data acquisition and compliant data storage activities. Partner closely with Qualification/Validation, IT, Engineering, and other project teams to ensure validation activities are completed in accordance with project requirements and GMP expectations. Required Skills & Qualifications 5-10 years of CSV/Computerized System Validation experience , preferably in a CDMO environment . Hands-on experience with Sartorius bioreactor validation . Experience validating Cytiva chromatography skid equipment . Experience with IQ/OQ/PQ execution . Experience with validation protocol changes, revisions, and execution . Experience creating Validation Summary Reports (VSRs) . Experience working in a GMP pharmaceutical/CDMO environment . Familiarity with Sartorius MFCS is highly preferred. Experience with Siemens Desigo or environmental control systems is preferred. Strong documentation, communication, and cross-functional collaboration skills. #J-18808-Ljbffr United Pharma Technologies Inc
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