Validation Specialist

QRC Group, LLC; Cidra (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

QRC Group, LLC in Cidra, Puerto Rico seeks a Validation Specialist to support development, execution and documentation of validation activities for molds and equipment, including IQ, OQ and PQ phases. The role involves creating and updating SOPs, ensuring compliance with project plans, and developing inspection programs for tooling and parts.

Requirements include a Bachelor in Science, 5+ years in an FDA-regulated setting, strong technical writing, and fluent English and Spanish communication to

Qualifications

• Bachelor in Science degree required.
• Experience in FDA-regulated industry (5+ years).
• Proven experience performing validation lifecycle activities.
• Strong technical writing and documentation skills.
• Read, write, speak English and Spanish fluently.

Responsibilities

• Plan, execute, and document validation lifecycle activities (IQ/OQ/PQ).
• Develop inspection programs for tooling and part setup.
• Update SOPs and ensure compliance with Product Development Plans.
• Prepare protocols, tests, and reports with traceability.

Skills

IQ/OQ/PQ validation

Gage R&R

Metrology tools

Technical writing

Bilingual EN/ES

Education

Bachelor in Science

Tools

CMM

Calipers

Micrometers

Vision inspection systems

Gage R&R methods

Job description

Cidra, Puerto Rico | Posted on 08/06/2026

Validation Specialist with a strong knowledge of injection molding processes to support the development, execution, and documentation of validation activities (Protocols, Tests, Reports).

• Familiarized with IQ, OQ and PQ validation phases for molds and equipment.
  
• IQ: Confirmation of Drawings (including mold attributes), Equipment, and Procedures (mold setup and operating), mechanical assessment of mold and equipment.
  
• Develop inspection programs and instructions for setup/positioning of tooling and parts.
  
• Assuring that all product development processes and relevant applicable documentation are executed according to the agreed Product Specific Design and Development Plans.
  
• Updating and defining Standard Operating Procedures (SOPs).
  
• Familiarized with Gage R&R methodology preferable.
  
• Preferably, familiarized with metrology equipment and methods such as calipers, micrometers, CMM, Programmable Vision Inspections Systems.
  

Requirements

• Bachelor in Science
  
• Experience in FDA regulated industry
  
• 5 years of experience performing validation lifecycle activities
  
• Techical writting skills
  
• Read, write, speak and understand English and Spanish