Validation Specialist

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 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).
  

Requirements
Bachelor in Sciences or Engineering