Computer Systems Compliance Specialist

1 week ago


Holly Springs, United States Validation & Engineering Group Full time

**Job Title:** Biotech Systems Validation Professional

About the Role:

This is an exciting opportunity to work with a leading services supplier in the biotechnology industry. As a Computer Systems Validation (CSV) Specialist, you will be responsible for ensuring that all computerized systems related to manufacturing, laboratory, and quality control comply with regulatory standards.

Duties and Responsibilities:

  • Develop protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure systems function within defined specifications.
  • Collaborate closely with quality assurance, IT, lab operations, and manufacturing teams to ensure system reliability, data integrity, and compliance.
  • Prepare and maintain detailed documentation for validation activities, including validation plans, test scripts, traceability matrices, and summary reports.
  • Support internal and external audits by providing necessary documentation and demonstrating compliance with validation and regulatory requirements.

Requirements:

  • Education: Bachelor's degree in Life Sciences, Computer Science, Engineering, or related fields.
  • Experience: Minimum of 3-5 years of experience in computer systems validation in the biotechnology or pharmaceutical industry.
  • Technical Skills: Knowledge of validation for LIMS, MES, and EBR systems in biotech environments.

Estimated Salary: $90,000 per annum, depending on qualifications and experience.



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