
Validation Engineer
Flexible & Integrated Technical Services
- Yauco, PR
- Permanente
- Tiempo completo
- Bachelor’s Degree in Engineering and at least two (2) years of exposure within the Pharmaceutical or Medical Devices industry.
- Bilingual (Spanish and English)
- Shift: Administrative, and according to business needs.
- Willingness to work in cleanroom or controlled environments.
- Availability to work flexible hours, including weekends, if required.
- Knowledge of safety procedures and compliance with EHS regulations
- Experience in:
- Generation & Execution Protocols; IQ, OQ, PQ.
- GMP, GDP, and FDA/ISO regulations.
- Risk Assessment tools (FMEA, HACCP, risk matrix)
- Calibration and Verification of instruments and equipment.
- Troubleshooting and root cause analysis.
- Validation engineering support of process and/or equipment upgrades, replacements, and modifications in the manufacturing environment.
- Develops, organizes, analyzes, and presents interpretation of results for operational issues or validation engineering projects of significant scope.
- Complete complex or novel assignments requiring the development of new and/or improved validation engineering techniques and procedures.
- Develop validation engineering policies and procedures.
- Generation & Execution Protocols; IQ, OQ, PQ.
- Implement tools, techniques, and processes to provide or create information to enable informed decision making within the teams.
- One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!