CSV Engineer

R Systems International Limited; Pune District, Bengaluru, New Delhi; On-site; INR 1,200,000 - 1,600,000; Full time

Job summary

R Systems International Limited in Pune is seeking an experienced CSV engineer to design and validate computer system validation protocols for pharmaceutical equipment and systems.

You will ensure GAMP compliance, conduct deviation investigations, and develop IQ/OQ/PQ documents for new equipment installations or modifications.

Qualifications

• 5-10 years of experience in CSV engineering in the pharmaceutical industry.
• Strong understanding of validation principles and regulations (e.g., FDA 21 CFR Part 11).
• Experience with GXP development and implementation.

Responsibilities

• Design, develop, test, and maintain CSV protocols for pharmaceutical equipment and systems.
• Collaborate with cross-functional teams to ensure GAMP compliance.
• Conduct deviation investigations and implement corrective actions to maintain data integrity.
• Develop IQ/OQ/PQ documents for new equipment installations or modifications.

Skills

CSV engineering

GAMP compliance

FDA 21 CFR Part 11

Deviation investigations

Tools

IQ/OQ/PQ documents

Job description

Roles and Responsibilities :

• Design, develop, test, and maintain CSV (Computer System Validation) protocols for pharmaceutical equipment and systems.
• Collaborate with cross-functional teams to ensure compliance with GAMP (Good Automated Manufacturing Practice) guidelines.
• Conduct deviation investigations and implement corrective actions to maintain data integrity.
• Develop IQ/OQ/PQ documents for new equipment installations or modifications.

Job Requirements :

• 5-10 years of experience in CSV engineering in the pharmaceutical industry.
• Strong understanding of computer system validation principles and regulations (e.g., FDA 21 CFR Part 11).
• Experience with GXP (Good X Practices) development and implementation.
• Proficiency in creating IQ/OQ/PQ documents using standard templates.