- Ponce, Ponce, Puerto Rico
- Full-time · Mid
- 2–3 years
Support validation, qualification, and continuous improvement activities within a regulated manufacturing environment.
Responsibilities
- Develop, execute, and support validation and qualification activities for manufacturing processes, equipment, test methods, and systems.
- Prepare, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Support Process Characterization Studies, Test Method Validation (TMV), and Inspection Method Validation (IMV).
- Develop and execute Design of Experiments (DOE) to evaluate process performance and identify improvement opportunities.
- Utilize Minitab to perform statistical analysis, process capability studies, data trending, and interpretation of validation results.
Requirements
- Bachelor's Degree in Engineering
- Nice to have: medical device industry
- Nice to have: pharmaceutical industry
- Nice to have: biotechnology industry
- Nice to have: FDA regulations