CQV Engineer

United Pharma Technologies Inc; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

United Pharma Technologies Inc. is seeking an experienced CQV Engineer to support qualification and validation projects in a fast-paced, GMP-regulated environment.

The role involves authoring, reviewing, and executing IQ/OQ/PQ protocols, preparing validation summary reports, and validating pharmaceutical manufacturing equipment. Collaboration with CQV, Validation, IT, Engineering and cross-functional teams is essential.

Qualifications

• 5–10 years of CQV/CSV experience in pharma/biotech.
• Hands-on IQ/OQ/PQ execution experience.
• Experience revising and executing validation protocols.
• Experience preparing validation summary reports.
• Strong GMP knowledge and documentation practices.
• Experience validating Sartorius bioreactors and Cytiva skid equipment.

Responsibilities

• Support changes, revisions, and updates to validation protocols.
• Author, review, and execute IQ/OQ/PQ protocols.
• Prepare Validation Summary Reports (VSRs) and other qualification documentation.
• Support qualification and validation of pharmaceutical manufacturing and process equipment.
• Work closely with CQV, Validation, IT, Engineering, and other cross-functional teams.
• Support validation activities for Sartorius and Cytiva equipment.
• Ensure validation activities are performed in accordance with GMP and compliance requirements.
• Support data acquisition and compliant data storage associated with validated systems.

Skills

CQV/CSV experience

IQ/OQ/PQ execution

Validation protocol revision

Validation documentation

Cross-functional collaboration

Tools

Sartorius Bioreactors 50L-500L

TFF systems

Cytiva chromatography skid equipment

Job description

Our client, a leading CDMO, is seeking an experienced CQV Engineer to support ongoing qualification and validation projects within a fast-paced regulated environment.

The consultant will work closely with the Qualification/Validation and IT teams to support validation protocol changes and revisions, execute qualification activities, and prepare validation documentation and summary reports.

Key Responsibilities

• Support changes, revisions, and updates to validation protocols.
• Author, review, and execute IQ/OQ/PQ protocols.
• Prepare Validation Summary Reports (VSRs) and other qualification documentation.
• Support qualification and validation of pharmaceutical manufacturing and process equipment.
• Work closely with CQV, Validation, IT, Engineering, and other cross-functional teams.
• Support validation activities for Sartorius and Cytiva equipment.
• Ensure validation activities are performed in accordance with applicable GMP and compliance requirements.
• Support data acquisition and compliant data storage associated with validated systems.

Equipment & Systems

Experience with the following equipment and systems is highly preferred:

• Sartorius Bioreactors - 50L to 500L
• TFF (Tangential Flow Filtration) Systems
• Incubators

Required Qualifications

• 5-10 years of CQV/CSV experience, preferably within a CDMO or pharmaceutical/biotechnology environment.
• Hands-on experience with IQ/OQ/PQ execution.
• Experience revising and executing validation protocols.
• Experience preparing validation summary reports.
• Strong experience validating Sartorius bioreactors.
• Experience validating Cytiva chromatography skid equipment.
• Knowledge of GMP-regulated validation practices and documentation.
• Strong communication and cross-functional collaboration skills.