Validation Engineer

United Pharma; California (MO); On-site; USD 75,000 - 120,000; Full time

Job summary

United Pharma is seeking a Validation Engineer (CQV) to support commissioning, qualification, and validation activities for GMP facilities, equipment, and critical systems in a regulated life sciences environment. This role emphasizes field presence and collaboration with cross-functional project teams to ensure systems are properly commissioned and ready for GMP operations.

The candidate will author and execute IQ, OQ, and PQ protocols, prepare validation documentation, and maintain cGMP

Qualifications

• 2–4 years of validation/CQV experience in regulated manufacturing environments.
• Hands-on equipment validation in life sciences facilities.
• Experience authoring and executing validation protocols.
• Knowledge of cGMP documentation and validation requirements.
• Ability to coordinate qualification activities with multiple teams.

Responsibilities

• Execute commissioning, qualification, and validation activities for GMP facilities and manufacturing systems.
• Develop, author, and execute IQ, OQ, and PQ protocols and validation documentation.
• Prepare validation protocols, summary reports, deviations, and protocol exceptions.
• Support qualification of facilities, cleanrooms, HVAC, and GMP utilities.
• Coordinate qualification schedules with Engineering, Manufacturing, and Quality.
• Review commissioning documentation and verify readiness prior to qualification testing.
• Maintain compliant validation documentation per cGMP requirements.
• Provide hands-on field support during startup, troubleshooting, and turnover.
• Participate in project meetings and provide CQV input.

Skills

CQV experience

GMP validation

Project coordination

Documentation

Job description

We are seeking a Validation Engineer (CQV) to support commissioning, qualification, and validation activities for GMP facilities, manufacturing equipment, and critical systems within a regulated life sciences environment. This role will have a strong field presence and work closely with cross-functional project teams to ensure systems are properly commissioned, qualified, documented, and ready for GMP operations.

Key Responsibilities:

• Execute commissioning, qualification, and validation activities for GMP facilities, equipment, utilities, and manufacturing systems.
• Develop, author, and execute IQ, OQ, and PQ protocols and associated validation documentation.
• Prepare validation protocols, summary reports, deviations, protocol exceptions, and other CQV deliverables.
• Support qualification of facilities, cleanrooms, HVAC systems, and GMP utilities.
• Coordinate qualification schedules and execution activities with Engineering, Manufacturing, Quality, and other project teams.
• Review commissioning documentation and verify system readiness prior to qualification testing.
• Participate in project meetings and provide CQV support and technical input.
• Maintain accurate and compliant validation documentation in accordance with cGMP requirements.
• Support equipment/system startup, troubleshooting, qualification, and turnover activities.
• Provide hands‑on field support within manufacturing and facility environments.

Required Qualifications:

• 2–4 years of validation/CQV experience in pharmaceutical, biotechnology, cell therapy, gene therapy, or other regulated manufacturing environments.
• Hands‑on equipment validation and CQV experience within a life sciences manufacturing environment.
• Direct experience authoring and executing validation protocols.
• Experience developing and executing IQ/OQ/PQ documentation, validation summary reports, and protocol exceptions.
• Strong understanding of cGMP documentation and validation requirements.
• Experience planning, scheduling, coordinating, and executing qualification activities.