Validation Standards Manager
Core
Lead validation standards and provide technical expertise across a manufacturing network to maintain validated states for equipment, utilities, cleaning, and computerized systems.
Role type
Senior Validation Standards Manager
Builds
Validated states for pharmaceutical manufacturing equipment and systems
Domain
Biopharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation strategy development, regulatory inspection support, risk-based judgment, team leadership, validation protocol authoring, continuous improvement implementation
Preferred skills
Cleaning validation, process validation lifecycle, computerized system validation, sterile manufacturing, project management, risk management
Technologies
Robotics, digital solutions, artificial intelligence
Responsibilities
Lead and coach validation engineers to deliver projects and maintain validated states; Develop and maintain Validation Master Plans, protocols, and reports; Act as technical lead during regulatory inspections; Define validation requirements and provide guidance to partners; Identify high-risk areas and implement standards/metrics; Support training and tools for scalable validation
Seniority
Senior, hands-on IC with leadership growth
