Senior Validation Specialist

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