Validation Engineer
Core
Validates and revalidates pharmaceutical products, equipment, and systems to ensure compliance with cGMPs and industry standards.
Role type
Validation Engineer
Builds
Validated equipment and systems for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment requalification, protocol preparation and execution, data analysis, report writing, deviation investigation, CA/PA implementation, HEPA filter testing, airflow pattern testing, analytical instrument operation, cGMP knowledge, aseptic techniques
Preferred skills
Statistical analysis, change control management, regulatory agency presentation
Technologies
Temperature/humidity dataloggers, thermocouples, lyophilizers, sterilizers, depyrogenation ovens, smoke generators, photometers, velocity meters
Responsibilities
Perform equipment requalifications per SOPs and coordinate testing with functional groups; Execute validation studies including protocol preparation, execution, and data analysis; Program and operate analytical instruments for chamber qualifications; Participate in deviation investigations and corrective/preventive actions; Conduct HEPA filter integrity and airflow pattern testing; Present validation data to regulatory agencies when necessary.
Seniority
Mid-level, hands-on IC
