Validation Specialist
About The Position
Validation Specialist with hands-on experience in executing validation and qualification activities across diverse areas, including: Process Packaging Manufacturing Laboratory Computer System Validation (CSV) Software Facilities and Utilities Site Acceptance Testing (SAT) & Factory Acceptance Testing (FAT) Commissioning and Decommissioning of Systems and Equipment Core Competencies: Skilled in drafting protocols, technical reports, and validation documentation in alignment with regulatory and industry standards (e.g., FDA, GMP). Proven ability to collaborate effectively with cross-functional teams—including Engineering, Quality, and Production—to ensure compliance, optimize processes, and support operational readiness.
Requirements
- Bachelor Degree in Science, or related field
- Minimum 5 years of experience in validations within a regulated industry.
- In-depth knowledge of GMP, FDA, and international standards.
- Hands-on experience in IQ/OQ/PQ, SAT/FAT, and commissioning.
- Ability to write clear and precise technical documentation.
- Excellent communication and teamwork skills.
- Bilingual (English/Spanish - understand, write and speak).
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
