CSV Specialist

QRC Group; Vega Baja (PR); Sur place; USD 70 000 - 110 000; Plein temps

Résumé du poste

QRC Group in Vega Baja, Puerto Rico seeks a seasoned CSV consultant to support installation and qualification of manufacturing equipment in a regulated environment. You will verify FAT IOQ progression and help establish documentation controls onsite.

Requirements: Bachelor in Science or related field; 5 years’ CSV experience in a regulated industry; proficiency with MS Word, Excel and MS Project; excellent technical writing; and bilingual English/Spanish.

Qualifications

• Bachelor in Science or related field.
• 5 years of CSV consulting experience in regulated industry.
• Proficiency with MS Word, Excel, and MS Project.
• Excellent technical writing skills.

Responsabilités

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

Connaissances

Bilingual: English/Spanish

Technical writing

MS Office proficiency

Formation

Bachelor in Science or related field

Outils

MS Word

MS Excel

MS Project

Description du poste

Vega Baja, Puerto Rico | Posted on 10/13/2026

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.