Senior Validation & Qualification Specialist

Description:

We are looking for an experienced and detail-oriented professional to support our validation and qualification activities, ensuring compliance, product quality, and operational excellence across our manufacturing operations.

🔹 Role Summary:
We are seeking a highly motivated Senior Validation & Qualification Specialist to lead and execute validation activities with a primary focus on Process Validation, Cleaning Validation, Continued Process Verification (CPV), and Validation Lifecycle Management. The role will support maintaining compliance with GMP requirements and ensuring all systems, equipment, and processes remain in a validated state.

🔹 Key Responsibilities
• Execute Process Validation and Cleaning Validation activities for manufacturing and packaging processes
• Develop and maintain Validation Master Plans (VMP), protocols, and reports
• Coordinate qualification activities for equipment, utilities, and manufacturing systems
• Perform validation impact assessments and risk-based evaluations for change controls
• Lead qualification activities for critical systems, including HVAC, water systems, compressed air, and cleanrooms
• Support Computerized Systems Validation (CSV) in line with GAMP 5 and ALCOA+ principles
• Prepare and review validation documentation in compliance with GMP and regulatory requirements
• Support internal audits, external inspections, and regulatory audits
• Evaluate deviations, non-conformities, and qualification findings with cross-functional teams

🔹 Qualifications & Requirements
• Bachelor’s degree in Pharmaceutical Engineering, Chemical Engineering, or a related scientific discipline
• Minimum 5 years of experience in validation and qualification within a pharmaceutical GMP environment
• Strong hands-on experience in Process Validation and Cleaning Validation
• Solid knowledge of equipment qualification, utilities qualification, and validation lifecycle management
• Familiarity with SFDA, WHO, FDA, EU GMP, and ICH Q8–Q10 requirements
• Experience with GAMP 5, CSV, and Data Integrity (ALCOA+) concepts
• Strong analytical, documentation, and problem-solving skills
• Excellent attention to detail and ability to work effectively across departments
• Saudi nationals and candidates residing in Saudi Arabia with a transferable IQAMA will be given priority