Principal Validation Engineer, CVRM
Core
Develops, implements, and maintains validation status of application equipment and manufacturing processes for high-volume drug product manufacturing.
Role type
Principal Validation Engineer
Builds
Sterilization systems, cleaning systems, filling equipment, and supporting equipment for sterile drug products.
Domain
Pharmaceutical manufacturing / Biotechnology / cGMP
Required skills
Equipment Commissioning and Qualification, Cycle Development, Performance Qualification, Re-Qualification, Cleaning Validation, Process Validation, Change Control documentation, Risk Assessment, Regulatory submissions, Project management, Mentorship
Preferred skills
Operational excellence, Industrial engineering
Technologies
Autoclaves, Parts washers, Sterile filling equipment
Responsibilities
Develop and manage detailed project plans and validation timelines; Author, execute, and summarize qualifications for sterilization and filling systems; Prepare change control documentation and protocols; Support project managers on implementation timelines; Present work during audits and Health Authority inspections; Procure and manage contractor support; Lead Risk Assessment sessions; Provide input into investigations; Mentor junior validation engineers.
Seniority
Principal, hands-on IC with mentorship