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Process Engineer
hace 1 semana
Job Overview
We are seeking a highly skilled Process Engineer to join our team at Flexible & Integrated Technical Services, LLC. This individual will be responsible for improving processes through preventive and corrective actions as part of Non-conformance and CAPA management.
About Us
Flexible & Integrated Technical Services, LLC is a service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and in the US. We pride ourselves in how we treat our resources' well-being while providing top-notch quality talent to our Pharmaceutical, Medical Device, and Manufacturing industry clients.
Your Key Responsibilities
- Investigate Non-conformances and CAPAs related to process, product, and facility performance to identify root causes and implement solutions.
- Write Validation Plans, IQ/OQ Protocols, IQ/OQ Reports, Design Qualification, User Requirements, and other necessary documentation to validate production equipment, enhance throughput, improve equipment performance, and ensure business continuity.
- Coordinate the repair and installation of equipment to ensure seamless manufacturing operations and continuous production flow.
What You'll Need
To be successful in this role, you will need:
- Bachelor's degree in Engineering and a minimum of five (5) years of exposure in Validation activities within the Pharmaceutical or Medical Device Industry.
- Excellent verbal/written communication skills in English and Spanish.
- Experience in Validation Life Cycle (IQ, OQ, PQ, CSV, FAT) and Facilities area GMP & GDP regulations.
Benefits
We offer a flexible, family-oriented work environment that prioritizes your well-being and growth. If you're looking for a challenging and rewarding opportunity, please apply.
