Pharma CQV Validation Engineer

United Pharma; Indiana (PA); On-site; USD 90,000 - 140,000; Full time

Job summary

United Pharma in the United States is seeking a CQV Engineer to provide engineering and CQV support for manufacturing equipment throughout implementation, commissioning, and qualification.

You will review drawings, coordinate with vendors and cross-functional teams, and author CQV documents such as URS, IQ/OQ/PQ, and reports, ensuring cGMP compliance and on-time delivery.

The role requires 5+ years of experience, strong problem-solving, and the ability to work onsite with multidisciplinary teams.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 5+ years of experience in engineering, commissioning, qualification, or equipment implementation in pharma/biotech.
• Strong knowledge of manufacturing equipment and systems.
• Experience with FAT, SAT, IQ/OQ/PQ and CQV lifecycle.
• Ability to read engineering drawings, P&IDs, and vendor documentation.
• Excellent communication and project coordination skills.
• Knowledge of cGMP and Good Documentation Practices.

Responsibilities

• Provide engineering and CQV support for equipment implementation, modification, commissioning, and qualification.
• Review drawings and documentation including P&IDs, equipment specs, datasheets.
• Coordinate with vendors, engineering, manufacturing, automation, Quality and other stakeholders.
• Author, review CQV documentation (URS, IQ/OQ/PQ, reports, deviations, turnover).
• Support field startup, commissioning, troubleshooting, and qualification activities.
• Manage assigned CQV activities against project schedules and report risks.
• Provide hands-on support in the field during installation, startup, testing, and qualification.
• Identify issues and drive resolution with project teams and vendors.

Skills

CQV lifecycle

Equipment commissioning

P&IDs reading

Vendor coordination

Technical documentation

Troubleshooting

cGMP

Project coordination

Education

Bachelor’s degree in Engineering

Job description

United Pharma in the United States is seeking a CQV Engineer to provide engineering and CQV support for manufacturing equipment throughout implementation, commissioning, and qualification.

You will review drawings, coordinate with vendors and cross-functional teams, and author CQV documents such as URS, IQ/OQ/PQ, and reports, ensuring cGMP compliance and on-time delivery.

The role requires 5+ years of experience, strong problem-solving, and the ability to work onsite with multidisciplinary teams.