CSV Specialist

QRC Group; Vega Baja (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

QRC Group in Vega Baja, Puerto Rico is seeking a qualified CSV consultant to support installation and qualification of manufacturing equipment in a regulated environment.

Responsibilities include FAT-to-IOQ; on-site installation and qualification; SOP development; documentation controls; and ensuring compliance. Fluency in English and Spanish is required.

Qualifications

• Bachelor in Science or related field.
• 5 years of experience as CSV consultant in regulated industry.
• Excellent technical writing skills.
• Bilingual: English and Spanish, speaking and writing.

Responsibilities

• Verify equipment installed and configured at the vendor site (FAT).
• Implement progression from FAT through IOQ per CC strategy.
• Installation at the manufacturing room for qualification activities.
• Qualification activities in the manufacturing room areas.
• Develop Standard Operating Procedures.
• Generate and routing of calibration and preventive maintenance forms.
• Development and approval of GxP and automation impact assessments.
• Provide alternatives to resolve documentation situations.
• Establish project communication and documentation controls.
• Assure consistent quality of activities that meets or exceeds the requirements.

Skills

Bilingual English/Spanish

Technical writing

MS Office proficiency

Education

Bachelor in Science or related field

Tools

MS Office

Job description

Vega Baja, Puerto Rico | Posted on 08/17/2026

To support the installation of several manufacturing soliddosage equipment such as but not limited to:

• Encapsulator
  
• Compression machine
  
• Hardness tester
  
• Encapsulation machine
  
• Auxiliary equipment
  

Main activities should include:

• Verificationof the equipment installed and configured at the vendor site (FAT).
  
• Implementthe progression from FAT through IOQ in accordance with the CC strategy.
  
• Installationat the manufacturing room for qualification activities.
  
• Qualificationactivities in the manufacturing room areas.
  
• Developmentof Standard Operating Procedures.
  
• Generationand routing of calibration and preventive maintenance forms.
  
• Developmentand approval of GxP and automation impact assessments.
  
• Providealternatives to resolve documentation situations.
  
• Establishproject communication and documentation controls.
  
• Assure consistent qualityof activities that meets or exceeds the requirements.
  

Requirements

• Bachelor in Science or related field
  
• 5 years of experience as CSV consultant in regulated industry.
  
• Experience with MS Office applications (Word, Excel and MS Project)
  
• Excellent technical writing skills.
  
• Bilingual: English and Spanish, speaking and writing.