Senior Validation Specialist

Katalyst-Healthcares-; Swiftwater (Monroe County); Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Conocimientos

Quality Validation

CAPA Management

Regulatory Knowledge

Risk Assessment

Cross-Functional Collaboration

Project Management

Technical Documentation

Root Cause Analysis

Educación

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Descripción del empleo

Requirements:

• Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
• Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
• Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
• Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
• Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
• Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
• Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.
• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
• 6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
• Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.

Key Competencies:

• Quality Validation & Compliance.
• CAPA Management.
• Regulatory Knowledge (FDA, GMP, GxP, QSR).
• Risk Assessment & Root Cause Analysis.
• Cross-Functional Collaboration.
• Project Management.
• Technical Documentation & Reporting.
• Continuous Improvement & Quality Excellence.