Life Sciences CSV Specialist - Regulatory System Validation

Lupin Pharmaceuticals; Florida; On-site; USD 90,000 - 130,000; Full time

Job summary

Lupin Pharmaceuticals, Inc. is seeking a Computer Validation Specialist to ensure computerized systems comply with regulatory requirements and quality standards.

The role supports development, execution, and review of validation deliverables for CSV projects, including systems integration and validation testing. The position collaborates with IT, Engineering, Quality, and R&D teams, and will help maintain inspection readiness and lifecycle validation status across lab and manufacturing

Qualifications

• Minimum of 4 years SDLC experience including system integration and validation testing.
• Software quality assurance and manual testing experience.
• Knowledge of FDA regulations, including 21 CFR Part 11.
• Strong IT network infrastructure knowledge and qualification requirements.
• Excellent communication and organizational skills.
• Ability to work independently and in a team setting.
• Experience with test automation tools.
• Experience validating laboratory systems, PLCs and/or SAP is a plus.

Responsibilities

• Prepare, review, and approve validation documents for CSV projects.
• Regulatory assessment for GxP and Part 11 relevance.
• Develop and review IQ/OQ/PQ protocols, test scripts and reports.
• Review validation docs for lab and manufacturing systems.
• Interface with IT, Engineering, Quality, R&D teams.
• Provide updates on projects and communicate risks.
• Maintain validation state through system lifecycle.
• Support high inspection readiness for CSV portfolio.

Skills

SDLC experience

Software QA

Manual testing

FDA 21 CFR Part 11

IT network infrastructure

Communication skills

Independent / team work

Test automation tools

Tools

Trackwise

Empower

SAP

Job description

Lupin Pharmaceuticals, Inc. is seeking a Computer Validation Specialist to ensure computerized systems comply with regulatory requirements and quality standards.

The role supports development, execution, and review of validation deliverables for CSV projects, including systems integration and validation testing. The position collaborates with IT, Engineering, Quality, and R&D teams, and will help maintain inspection readiness and lifecycle validation status across lab and manufacturing