CSV Specialist: Validation & Equipment Qualification

QRC; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

QRC Group, LLC, based in Puerto Rico, seeks a CSV consultant to support installation of solid dosage manufacturing equipment, including encapsulators, checkweighers, and compression machines. You will help verify FAT and IOQ and develop SOPs for QC and regulatory compliance.

Responsibilities span installation, qualification in manufacturing rooms, GxP assessments, and documentation controls. Fluency in English and Spanish is required to ensure clear cross‑functional communication.

Qualifications

• Bachelor in Science or related field is required.
• 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.

Responsibilities

• Verify 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.

Skills

CSV validation experience

Regulatory compliance

Education

Bachelor in Science or related field

Tools

MS Office: Word, Excel, MS Project

Job description

QRC Group, LLC, based in Puerto Rico, seeks a CSV consultant to support installation of solid dosage manufacturing equipment, including encapsulators, checkweighers, and compression machines. You will help verify FAT and IOQ and develop SOPs for QC and regulatory compliance.

Responsibilities span installation, qualification in manufacturing rooms, GxP assessments, and documentation controls. Fluency in English and Spanish is required to ensure clear cross‑functional communication.