CQV engineer
Job in
Princeton, Mercer County, New Jersey, 08543, USA
Listed on 2026-09-22
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-09-22
Job specializations:
-
Pharmaceutical
Validation Engineer, Pharma Engineer, Pharmaceutical Manufacturing
Job Description & How to Apply Below
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
- 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.
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.
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