Data Validation Specialist

2 days ago


Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time
Job Description

About NUSANTARA PRIME CONSULTING PTE. LTD.

We are a consulting firm that helps clients achieve their goals through expert advice and services.

$80,000 - $110,000 per annumJob Summary

The CSV Engineer will be responsible for managing Computer System Validation (CSV) lifecycle from design to execution phases.

This includes preparing CSV documents and protocols, executing automated equipment and/or control systems, and closing executed protocols.

The ideal candidate will have a strong understanding of validation lifecycle, compliance requirements, and current Good Manufacturing Practices (cGMP).

Key Responsibilities
  • Manage CSV lifecycle from design to execution phases;
  • Prepare CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols;
  • Perform troubleshooting during test execution;
  • Execute thermal mapping activities;
  • Write execution-related deviations and change requests;
  • Any other task as assigned by Supervisor/Manager;
Requirements
  • Diploma/Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls;
  • Min. 3 years of experience in CSV preferably in a biotech facility;
  • Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and cGMP;
  • Familiar with Health Authorities standards (e.g., FDA CFR and EU);
  • Knowledge of thermal mapping validation and usage of data logger is a plus;
  • Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams;
  • Must be team player, curious with strong analytical and organizational skills;
Benefits
  • A competitive salary range of $80,000 - $110,000 per annum;
  • A comprehensive benefits package including medical, dental, and vision insurance;
  • A generous paid time off policy;
  • Ongoing training and professional development opportunities;


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