QRC Group, LLC

Validation Specialist

📍 Location
Caguas, PR
⏰ Job Type
Full-time
📅 Posted
May 29, 2026
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Job Description

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 teamsincluding Engineering, Quality, and Productionto 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 cl...

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