CQV Consultant

United Pharma; Ohio; On-site; USD 85,000 - 120,000; Full time

Job summary

United Pharma seeks a CQV Consultant to support commissioning, qualification, and validation across pharmaceutical manufacturing systems, including CIP systems and manufacturing support equipment.

You will perform system walkdowns, develop IQ/OQ/PQ protocols, prepare qualification reports, and provide process engineering support while ensuring cGMP compliance. This role requires collaboration with project teams to deliver timely, compliant results.

Qualifications

• Bachelor's degree in Chemical Engineering or related field (or equivalent experience).
• Minimum 1 year in commissioning, qualification and validation within pharma/manufactured environment.
• Experience with system walkdowns, P&ID reviews, and qualification execution.
• Knowledge of IQ, OQ, PQ protocols, documentation and final reporting.
• Familiarity with CIP systems and pharmaceutical process equipment.
• Strong written and verbal communication skills; able to multitask in fast-paced projects.
• Ability to collaborate across project teams, quality and engineering.

Responsibilities

• Perform system walkdowns, P&ID reviews, equipment commissioning, and ETOP prep.
• Execute C&Q activities for pharmaceutical process systems and equipment.
• Develop IQ, OQ, PQ protocols and prepare final qualification reports.
• Provide process engineering support for CIP systems and equipment.
• Review system documentation, data packages, calibration certificates, and trends.
• Support project lead in coordinating deliverables and schedules.
• Track and report project progress to meet timelines and scope.
• Maintain qualification documentation, protocols, reports and records.
• Identify issues and support timely troubleshooting and resolution.
• Promote cGMP practices and regulatory compliance.

Skills

Communication

Collaboration

Project coordination

Education

Bachelor's degree in Chemical Engineering

Tools

IQ/OQ/PQ protocols

Job description

We are seeking a CQV Consultant to support commissioning, qualification, and validation activities across pharmaceutical manufacturing systems, including Clean-in-Place (CIP) systems and manufacturing support equipment. The consultant will perform system walkdowns, execute qualification activities, prepare technical documentation, and provide process engineering support while ensuring compliance with cGMP and regulatory requirements.

Key Responsibilities:

• Perform system walkdowns, P&ID reviews, equipment commissioning, and preparation of Equipment Turnover Packages (ETOPs).
• Execute Commissioning and Qualification (C&Q) activities for pharmaceutical process systems and manufacturing equipment.
• Develop and execute IQ, OQ, and PQ protocols and prepare final qualification reports.
• Provide process engineering support for CIP systems and pharmaceutical process equipment.
• Review system documentation, technical data packages, calibration certificates, and process trends.
• Support the project lead in coordinating project deliverables, execution schedules, and overall project activities.
• Track, document, and report project progress to ensure deliverables meet established timelines and scope.
• Maintain accurate qualification documentation, protocols, reports, and supporting records.
• Identify technical and compliance-related issues and support timely troubleshooting and resolution.
• Promote cGMP practices and regulatory compliance throughout project execution.

Required Qualifications:

• Bachelor's degree or higher in Chemical Engineering or a related engineering or scientific discipline; equivalent relevant experience may be considered.
• Minimum 1 year of experience in Commissioning, Qualification, and Validation within a pharmaceutical or regulated manufacturing environment.
• Experience with equipment commissioning, system walkdowns, P&ID reviews, and qualification execution.
• Knowledge of IQ, OQ, PQ protocols, documentation, and final reporting.
• Familiarity with CIP systems and pharmaceutical process equipment.
• Ability to analyze technical issues, troubleshoot problems, and manage multiple priorities in a fast-paced project environment.
• Strong written and verbal communication skills.
• Ability to collaborate effectively with project teams, engineering, quality, and other cross-functional stakeholders.