Validation Specialist

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

Job summary

QRC Group in Cidra, Puerto Rico is seeking a Validation Specialist with strong knowledge of injection molding processes to support validation activities across protocols, tests, and reports.

Responsibilities include leading IQ, OQ, and PQ validation for molds and equipment, developing inspection programs, ensuring SOPs are updated, and maintaining compliance in FDA-regulated environments; bilingual English/Spanish required.

Qualifications

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

Responsibilities

• Validate development, execution, and documentation of validation activities (Protocols, Tests, Reports).
• IQ, OQ and PQ validation phases for molds and equipment.
• Develop inspection programs and instructions for setup/positioning of tooling and parts.
• Assure all product development processes and relevant documentation are executed per the Product Specific Design and Development Plans.
• Update and define Standard Operating Procedures (SOPs).
• Familiarized with Gage R&R methodology; metrology equipment knowledge preferred.

Skills

Validation lifecycle

IQ/OQ/PQ

Gage R&R

Metrology knowledge

Technical writing

Bilingual EN/ES

Education

Bachelor of Science

Tools

CMM

Calipers

Micrometers

Vision Inspection Systems

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