CQV Engineer - Lab

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

Description: We’re seeking a highly skilled Sr. Engineer – Process Development (CQV) to support automated and semi-automated combination product assembly, labeling, and packaging operations within a GMP Final Drug Product (FDP) manufacturing environment. In this role, you’ll lead commissioning, qualification, and validation activities for new and existing equipment and processes, ensuring full compliance with FDA regulations and internal quality standards. You’ll author and execute validation protocols (IQ/OQ/PQ), maintain master validation plans, and serve as the site’s technical expert for automated systems and combination product validation.

The ideal candidate brings deep expertise in CQV within GMP-regulated environments, along with hands-on experience in automated equipment, labeling, and packaging processes. You’ll collaborate closely with Engineering, Quality, and Manufacturing teams to deliver robust, validated systems that support 24/7 production operations. Flexibility to support on-site and off-shift validation activities is require

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Skills: Process, CQV, Manufacturing, Packagi