VALIDATION ENGINEER
Core
Provides technical support for equipment/system initial validation, requalification, and improvement to ensure compliance with cGMPs in a pharmaceutical plant.
Role type
Validation Engineer
Builds
Validated pharmaceutical manufacturing systems and equipment
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
cGMP knowledge, protocol drafting, data analysis, statistical analysis, report writing, deviation investigation, equipment operation
Preferred skills
None stated
Technologies
Temperature/humidity dataloggers, lyophilizers, sterilizers, incubators
Responsibilities
Drafts and executes validation protocols; analyzes test data and prepares final reports; operates analytical instruments for chamber qualifications; participates in system specification, installation, and troubleshooting; conducts deviation investigations.
Seniority
Individual Contributor