VALIDATION ENGINEER
Core
Provides technical support for equipment/system initial validation, requalification, and improvement to ensure compliance with cGMPs in a pharmaceutical manufacturing plant.
Role type
Validation Engineer (cGMP)
Builds
Validated pharmaceutical manufacturing systems and equipment
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
cGMP knowledge, equipment commissioning, protocol drafting, data analysis, statistical analysis, report writing, deviation investigation, root cause analysis
Preferred skills
Certified to enter Controlled Areas (Grade D, C, B, A), experience with analytical instruments
Technologies
temperature/humidity dataloggers, lyophilizers, sterilizers, incubators
Responsibilities
Drafts and executes validation protocols; coordinates testing with functional groups; programs and operates analytical instruments; participates in system improvement teams; conducts deviation investigations.
Seniority
Individual Contributor