Associate Director, Validation

Responsibilities

• Lead the Qualification and Validation teams at the site
• Establish operational objectives and systems to drive employee engagement
• Lead system validation projects for laboratory instruments and equipment following ISPE GAMP 5
• Author and execute validation documentation including System Validation Plans, Risk Assessments, IQ, OQ, PQ, and Test Scripts
• Represent Validation during GMP and regulatory agency inspections
• Identify opportunities to reduce operational costs and improve project delivery efficiency
• Provide hands-on troubleshooting and problem solving at the Gemba
• Manage the annual OPEX budget for the Validation department
• Develop and mentor staff to build technical and personal competence

Requirements

• Bachelor’s degree in Life Sciences or Engineering
• Minimum 10 years of experience in biopharmaceutical or related engineering/quality roles
• At least 5 years in a leadership role
• Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements
• Strong understanding of Validation Lifecycle (GAMP 5) principles
• Experience with calibration and maintenance management software
• Proficiency in electronic document management systems
• Strong technical writing skills for qualification documents and SOPs
• Significant experience with controls, automation, and computer system validation
• Knowledge of cGMP, root cause analysis, and risk assessment techniques

Preferred Qualifications

• Knowledge of pharmaceutical equipment such as bioreactors, centrifuges, and HVAC systems
• Experience writing computer system test scripts and validation protocols

About the Company

ProKidney is a biotechnology company focused on developing cell therapies for kidney disease.