Qualifications

• 5-7 years of experience in Computer System Validation (CSV) within Pharmaceutical or Biotechnology settings.
• Proven track record in validating laboratory or scientific software in GxP environments.
• Familiarity with bioinformatics, genomics, NGS, or computational biology workflows.
• Experience with scientific algorithms and proficiency in Python or R for data analysis.
• Strong understanding of GAMP 5, 21 CFR Part 11, and principles of data integrity.
• Ability to work effectively with cross-functional teams including Quality, IT, Bioinformatics, and Laboratory departments.

Responsibilities

• Validate bioinformatics software and ensure accuracy of data analysis systems.
• Develop and execute comprehensive Validation Plans and Risk Assessments.
• Create and implement URS, IQ/OQ/PQ protocols, and Validation Summary Reports.
• Validate scientific algorithms and oversee automated data processing workflows.
• Conduct impact assessments and assist with change control activities in a regulated environment.
• Ensure adherence to GAMP 5, 21 CFR Part 11 standards, and maintain data integrity throughout processes.

Benefits

• Opportunity to work with a leading biotech client on impactful projects.
• Exposure to cutting-edge bioinformatics software and genomic analysis platforms.
• Chance to collaborate with interdisciplinary teams in a regulated environment.
• Support for career development in a niche area of Computer System Validation.