Senior Validation Leader - CAPA & Compliance

Creative Solutions Services, LLC; Swiftwater (Monroe County); On-site; USD 90,000 - 140,000; Full time

Job summary

Creative Solutions Services, LLC in the United States seeks an experienced Quality Validation professional to lead validation activities across equipment, processes, facilities, and computerized systems. You will review documentation, participate in CAPA investigations, and ensure compliance with QSR, GMP and FDA requirements in a fast-paced, regulated manufacturing environment.

The role requires strong cross-functional collaboration with Quality, Manufacturing, Engineering, Validation, and

Qualifications

• Experience supporting validation activities across equipment, processes, facilities, and computerized systems.
• Preferred experience in aseptic filling and sterile manufacturing environments.
• Proven CAPA investigations leadership and activities.
• Strong knowledge of QSR, GxP, and FDA regulatory practices.
• Excellent communication and cross-functional collaboration skills.
• Ability to manage multiple projects with aggressive timelines.

Skills

Quality Validation

CAPA Management

Regulatory Knowledge

Risk Assessment

Cross-Functional Collaboration

Project Management

Technical Documentation

Root Cause Analysis

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Job description

Creative Solutions Services, LLC in the United States seeks an experienced Quality Validation professional to lead validation activities across equipment, processes, facilities, and computerized systems. You will review documentation, participate in CAPA investigations, and ensure compliance with QSR, GMP and FDA requirements in a fast-paced, regulated manufacturing environment.

The role requires strong cross-functional collaboration with Quality, Manufacturing, Engineering, Validation, and