Validation Engineer
Core
Validates and revalidates new or modified products, equipment, and systems in a pharmaceutical manufacturing environment.
Role type
Validation Engineer
Builds
Validated equipment and systems for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Equipment validation studies, SOP execution, data analysis, report writing, deviation investigations, cGMP knowledge, aseptic techniques, analytical instrument operation, airflow pattern testing, change control
Preferred skills
Statistical analysis, team collaboration, initiative, regulatory agency presentation
Technologies
Temperature/humidity dataloggers, thermocouples, lyophilizers, sterilizers, depyrogenation ovens, smoke generators, photometers, velocity meters
Responsibilities
Perform equipment requalifications per SOPs, execute validation studies including protocol preparation and data analysis, program and operate analytical instruments for chamber qualifications, participate in deviation investigations and CA/PA, perform HEPA filter integrity and airflow pattern testing, participate in regulatory agency presentations
Seniority
Mid-level, hands-on IC
