CQV engineer

United Pharma Technologies Inc; Princeton (NJ); On-site; USD 110,000 - 160,000; Full time

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.

Skills

CSV/Validation experience

Cross-functional collaboration

Documentation

Communication

GMP/compliance

Tools

Sartorius MFCS

Siemens Desigo

Cytiva equipment

IQ/OQ/PQ tools

Job description

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.