Validation Engineer - Spark Life Solutions Inc
Miami, FL 33101
About the Job
Roles & Responsibilites:
- Develop, write installation (IQ), operational (OQ) and performance qualification (PQ) protocols for production equipment, laboratories and process validation for production processes.
- 5 to 7 years of validation engineering experience with equipment, and / or facilities within a cGMP or FDA regulated environment - small facility - 6 production rooms - limited equipment - R&D only... - prepping to move to commercial GMP/cGMP process experience.
- Clear understanding of industry regulated guidelines for the validation of cGMP facilities
- Relevant experience within the Pharmaceutical, or Biotechnology industries
- Coordinate execution of validation protocols
- Analyze validation test data - determine systems or processes have met validation criteria.
- Prepare validation or performance qualification protocols for manufacturing processes, systems, equipment for production.
- Prepare summary reports for the completed qualifications including recommendations
- Excellent verbal and written communication skills
Source : Spark Life Solutions Inc
