CSV Validation Engineer – GMP Manufacturing

QRC Group, LLC; Vega Baja (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

QRC Group, LLC in Vega Baja, Puerto Rico seeks an experienced CSV consultant to support installation and qualification of manufacturing equipment, including FAT to IOQ progression, with emphasis on documentation and QA standards.

The role requires a Bachelor in Science or related field, 5 years of CSV experience in regulated environments, strong MS Office skills, and excellent technical writing abilities in English and Spanish.

Qualifications

• 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.

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.
• Install equipment 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.
• Develop 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 meet or exceed the requirements.

Skills

Technical writing

Bilingual English/Spanish

Education

Bachelor in Science or related field

Tools

MS Office (Word, Excel, MS Project)

Job description

QRC Group, LLC in Vega Baja, Puerto Rico seeks an experienced CSV consultant to support installation and qualification of manufacturing equipment, including FAT to IOQ progression, with emphasis on documentation and QA standards.

The role requires a Bachelor in Science or related field, 5 years of CSV experience in regulated environments, strong MS Office skills, and excellent technical writing abilities in English and Spanish.