Quality Validation Engineer

The Quality Validation Engineer is responsible for supporting and leading quality validation, quality systems, CAPA, and regulatory compliance activities within a pharmaceutical or biopharmaceutical manufacturing environment. The role ensures that equipment, processes, facilities, computerized systems, and related documentation meet FDA, GMP, GxP, and QSR requirements.

• 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.
• 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.
• 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.
• 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.

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

Skills need :

• 10+ years of experience in a Quality/Validation role
• Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
• Extensive CAPA experience
• Extensive Quality Systems Experience
• Extensive experience in high-speed aseptic filling operations and sterile manufacturing environments.
• Lead and support validation activities for equipment, processes, facilities, utilities, computerized systems, and related documentation.
• Develop, review, execute, and approve validation protocols and reports.
• Lead CAPA investigations, including root cause analysis, corrective actions, preventive actions, and effectiveness checks.
• Support deviation investigations, change controls, risk assessments, and quality assessments.
• Ensure validation activities comply with FDA, GMP, GxP, QSR, and applicable regulatory requirements.
• Support validation activities for high-speed aseptic filling and sterile manufacturing operations.
• Review and maintain validation documentation and technical reports.
• Collaborate with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs teams.
• Identify and mitigate quality and compliance risks associated with manufacturing and validation activities.
• Manage multiple validation projects and ensure deliverables are completed within established timelines.
• Support regulatory inspections, internal audits, and inspection-readiness activities.
• Provide technical guidance on quality validation and quality system requirements.
• Drive continuous improvement and quality excellence initiatives.
• Communicate project status, risks, issues, and recommendations to cross-functional stakeholders.