Senior CQV Engineer – GMP Automation & Validation

United Pharma; Kentucky; On-site; USD 120,000 - 160,000; Full time

Job summary

United Pharma is seeking a Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product manufacturing environment.

You will lead commissioning, qualification and validation activities for equipment and processes, ensuring FDA compliance and internal quality standards. The ideal candidate brings deep CQV expertise in GMP environments, hands-on experience with automated equipment,

Qualifications

• Experience leading CQV activities in GMP environments.
• Hands-on experience with automated labeling and packaging equipment.
• Ability to author IQ/OQ/PQ validation protocols and master plans.
• Ability to work cross-functionally with Engineering, Quality, Manufacturing.

Responsibilities

• Lead commissioning, qualification, and validation of new and existing equipment.
• Author and execute validation protocols (IQ/OQ/PQ).
• Serve as site technical expert for automated systems and combination product validation.

Skills

CQV

Process development

GMP experience

Automation equipment

Job description

United Pharma is seeking a Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product manufacturing environment.

You will lead commissioning, qualification and validation activities for equipment and processes, ensuring FDA compliance and internal quality standards. The ideal candidate brings deep CQV expertise in GMP environments, hands-on experience with automated equipment,