CQV Engineer
Job in
Merrimack, Hillsborough County, New Hampshire, 03054, USA
Listed on 2026-09-24
Listing for:
United Pharma Technologies Inc
Full Time
position Listed on 2026-09-24
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Regulatory Compliance Specialist, Quality Engineering
Job Description & How to Apply Below
Location:
Holly spring, NC AND West Lebanon, NH
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
- 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.
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