CQV Engineer: GMP Validation (Bioreactors/Chromatography)

United Pharma Technologies Inc

Princeton (NJ)

On-site

USD 110,000 - 160,000

Full time

6 days ago

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Job summary

United Pharma Technologies Inc. seeks an experienced CQV Engineer to support a fast-paced qualification and validation environment in a CDMO setting.

You will partner with Validation, IT, Engineering, and project teams to execute IQ/OQ/PQ protocols and prepare VSRs for Sartorius MFCS data acquisition and Cytiva systems. Responsibilities include reviewing and updating validation protocols, validating Sartorius bioreactors (50L-500L), Cytiva skids, TFF systems, incubators, and chromatography

Qualifications

5-10 years of CSV/Computerized System Validation experience 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 and VSRs.

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 with Qualification/Validation, IT, Engineering, and other project teams to ensure GMP compliance.