Validation Specialist

Zohorecruit; Puerto Rico; On-site; USD 80,000 - 100,000; Full time

Job summary

Zohorecruit is seeking a Validation Specialist with strong knowledge of injection molding processes to support the development, execution, and documentation of validation activities (Protocols, Tests, Reports) in FDA-regulated environments.

You will work with IQ, OQ, and PQ for molds and equipment, develop inspection programs, update SOPs, and ensure compliance with Product Development Plans. English/Spanish communication is required.

Qualifications

• 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

• Develop validation protocols, tests and reports for validation activities.
• Execute IQ, OQ and PQ for molds and equipment.
• Develop inspection programs and setup instructions for tooling and parts.
• Ensure all product development processes follow the Design and Development Plans.
• Update and define Standard Operating Procedures (SOPs).
• Familiarity with metrology methods and equipment is a plus.

Skills

Validation lifecycle

Technical writing

Bilingual EN/ES

IQ/OQ/PQ

Education

Bachelor in Science

Tools

Gage R&R

CMM

Calipers

Micrometers

Vision Inspection System

Job description

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
  
• Technical writing skills
  
• Read, write, speak and understand English and Spanish