What are the responsibilities and job description for the CQV Engineer position at United Pharma Technologies Inc?
Role: CQV Engineer
Location: Princeton, NJ
Position Overview:
We are seeking an experienced CQV Engineer to support ongoing qualification and validation projects within a fast-paced CDMO environment. The consultant will partner closely with CQV, Validation, and IT teams to support protocol revisions, execution, and validation documentation.
Key Responsibilities:
- Review, revise, and execute IQ/OQ/PQ qualification protocols and related validation documentation.
- Develop and complete Validation Summary Reports (VSRs) and supporting qualification records.
- Support qualification of Sartorius and Cytiva process equipment.
- Perform qualification activities for 50L–500L bioreactors/reactors, incubators, TFF systems, and chromatography skids.
- Support validation of environmental control systems, including Siemens Desigo.
- Work with Sartorius MFCS for data acquisition, data retrieval, and compliant data storage.
- Collaborate with Validation, CQV, IT, Engineering, and other cross-functional teams to resolve protocol and execution issues.
- Ensure qualification activities are performed in accordance with GMP and applicable validation requirements.
Required Qualifications:
- 5–10 years of CQV/CSV/Validation experience, preferably within a CDMO or pharmaceutical manufacturing environment.
- Hands-on experience with IQ/OQ/PQ protocol execution and revisions.
- Experience preparing Validation Summary Reports.
- Strong experience qualifying Sartorius bioreactors/process equipment.
- Experience with Cytiva chromatography skids.
- Familiarity with TFF/filtration systems, incubators, and bioreactors/reactors.
- Experience with Sartorius MFCS and/or compliant process data acquisition systems.
- Familiarity with Siemens Desigo or similar environmental/building control systems.
- Strong understanding of GMP validation and documentation practices.