Validation Engineers

QRC Group, LLC; Caguas (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

QRC Group, LLC in Caguas, Puerto Rico seeks a Validation Engineer to support sterile manufacturing validation activities across plant operations, facilities, equipment, and room requalification. The role involves authoring and executing protocols, supporting field execution, documenting results, resolving discrepancies, and owning validation deliverables through closeout.

The position requires a Bachelor’s degree in Engineering, 5+ years of validated experience in a regulated setting, hands-on

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 5 years of validation experience in a regulated environment.
• Hands-on IQ/OQ/PQ authoring and execution experience.
• Experience supporting equipment, systems, facilities, cleanroom, and/or regulated manufacturing validation.
• Working knowledge of cGMP and 21 CFR 210/211.
• Ability to work on-site in El Paso, Texas.

Responsibilities

• Author and execute commissioning and qualification protocols and reports, including IQ/OQ/PQ.
• Own validation deliverables through execution, discrepancy resolution, and closeout.
• Execute field activities and document results in accordance with applicable validation requirements.
• Support equipment, systems, facilities, utilities, cleanroom, room requalification, and project validation activities as assigned.
• Perform risk-based assessments and support FMEA activities where applicable.
• Coordinate validation deliverables with QA, Engineering, and Manufacturing.
• Support multiple concurrent projects, depending on assignment.

Skills

IQ/OQ/PQ execution

Validation execution

Regulatory knowledge

Cross-functional coordination

Education

Bachelor’s degree in Engineering

Tools

Kneat

FMEA

Job description

Caguas, Puerto Rico | Posted on 08/17/2026

Weare seeking ValidationEngineer professionals to support validationactivities for sterile manufacturing, plant operations, facilities, equipment,systems, room requalification, and project-based validation initiatives.Assignment may include one or more active site projects, depending on projectneed. The role includes authoring and executing protocols, supporting fieldexecution, documenting results, resolving discrepancies, and owning validationdeliverables through closeout.

Requirements

Project Assignment Areas

• Grade DManufacturing Environment project, including Central Dust Extraction, Grade Darea/suite qualification, and equipment relocation validations.
  
• Bulk IPA Storagesystems validation.
  
• Plant operationsand quality project validation scope.
  
• Facilities-relatedvalidations for designated engineers, including HVAC, utilities, cleanroom, andBMS.
  

Key Responsibilities

• Author andexecute commissioning and qualification protocols and reports, includingIQ/OQ/PQ.
  
• Own validationdeliverables through execution, discrepancy resolution, and closeout.
  
• Execute fieldactivities and document results in accordance with applicable validationrequirements.
  
• Supportequipment, systems, facilities, utilities, cleanroom, room requalification, andproject validation activities as assigned.
  
• Performrisk-based assessments and support FMEA activities where applicable.
  
• Coordinatevalidation deliverables with QA, Engineering, and Manufacturing.
  
• Support multipleconcurrent projects, depending on assignment.
  

Required Qualifications

• Bachelor’s degreein Engineering or a related technical field.
• Minimum 5 yearsof validation experience in a regulated environment.
• Hands-on IQ/OQ/PQauthoring and execution experience.
• Experiencesupporting equipment, systems, facilities, utilities, cleanroom, and/orregulated manufacturing validation.
• Working knowledgeof cGMP and 21 CFR 210/211.
• Ability to workon-site in El Paso, Texas.

Preferred Qualifications

• Experiencewith Kneat.
• ISO14971 / FMEA experience.
• Cleanroom/ ISO 14644 experience.
• Validationleadership experience, where applicable.