CQV Engineer – GMP Validation for Pharma

Stark Pharma Solutions Inc; Charlotte (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a CQV Engineer with strong experience in pharmaceutical manufacturing and regulated environments to support commissioning, qualification, and validation activities for facilities, utilities, equipment, and systems.

The role collaborates with Engineering, Quality, Manufacturing, and Project teams to develop, execute CQV protocols (IQ/OQ/PQ) and ensure compliance with GMP, FDA, and GxP requirements, while driving continuous improvement projects.

Qualifications

• 3+ years of experience in CQV, commissioning, qualification, or validation in pharmaceutical/biotech.
• Hands-on IQ/OQ/PQ experience.
• Experience with CQV protocols and reports.
• Knowledge of GMP, FDA, GxP regulations and validation.
• Strong documentation, analytical, and communication skills.
• Ability to work with cross-functional teams.

Responsibilities

• Develop, execute, and document commissioning and qualification protocols.
• Perform IQ, OQ, PQ activities for equipment, utilities, and systems.
• Support commissioning and qualification of pharmaceutical manufacturing facilities and equipment.
• Prepare and maintain CQV protocols, reports, and validation documentation.
• Support FAT, SAT, commissioning, and qualification activities.
• Work with Engineering, Quality, Manufacturing, and Project teams to resolve CQV issues.
• Support deviations, investigations, change controls, and CAPA activities.
• Ensure CQV activities comply with GMP, FDA, and GxP requirements.
• Support continuous improvement and project execution.

Skills

Documentation

Analytical skills

Communication

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Job description

Stark Pharma Solutions Inc. is seeking a CQV Engineer with strong experience in pharmaceutical manufacturing and regulated environments to support commissioning, qualification, and validation activities for facilities, utilities, equipment, and systems.

The role collaborates with Engineering, Quality, Manufacturing, and Project teams to develop, execute CQV protocols (IQ/OQ/PQ) and ensure compliance with GMP, FDA, and GxP requirements, while driving continuous improvement projects.