CSV Specialist

Carolina - Puerto Rico

Monthly Salary: Not Disclosed

Experience Required: 5years

Posted on: 26-08-2025

Vacancies: 1 Vacancy

Job Summary

CSV Specialist to support the installation of several manufacturing solid dosage equipment such as but not limited to:

Encapsulator
Checkweigher
Compression machine
Hardness tester
Encapsulation machine
Auxiliary equipment

Main activities should include:

Verification of the equipment installed and configured at the vendor site (FAT).
Implement the progression from FAT through IOQ in accordance with the CC strategy.
Installation at the manufacturing room for qualification activities.
Qualification activities in the manufacturing room areas.
Development of Standard Operating Procedures.
Generation 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.

Requirements

Bachelor in Science or related field
2-3 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.

CSV Specialist to support the installation of several manufacturing solid dosage equipment such as but not limited to:Encapsulator CheckweigherCompression machineHardness testerEncapsulation machineAuxiliary equipmentMain activities should include:Verification of the equipment installed and configur...