Senior Validation Specialist

The Senior Validation Specialist is responsible for leading and supporting validation, quality systems, CAPA, and regulatory compliance activities within a highly regulated pharmaceutical or biopharmaceutical manufacturing environment. The role supports the validation of equipment, processes, facilities, utilities, computerized systems, and related documentation while ensuring compliance with FDA, GMP, GxP, and QSR 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
• Lead and support validation activities for equipment, processes, facilities, utilities, computerized systems, and documentation.
• Develop, review, execute, and approve validation protocols, test plans, and validation reports.
• Lead and manage CAPA investigations, including root cause analysis, corrective actions, preventive actions, and effectiveness checks.
• Support deviation investigations, change controls, and risk assessments related to validation activities.
• Ensure validation programs comply with FDA, GMP, GxP, QSR, and applicable regulatory requirements.
• Support validation activities within aseptic filling and sterile manufacturing operations.
• Review technical and quality documentation for accuracy, completeness, and compliance.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs teams.
• Identify validation risks and develop appropriate mitigation strategies.
• Manage multiple validation projects and ensure deliverables are completed within established timelines.
• Support audits, regulatory inspections, and inspection-readiness activities.
• Provide technical guidance and mentoring to validation team members.
• Maintain validation records and ensure proper documentation throughout the validation lifecycle.
• Identify opportunities for continuous improvement and quality excellence.
• Communicate project status, risks, issues, and recommendations to relevant stakeholders.