Computer Systems Validation Specialist for Biotechnology Industry

4 days ago


Holly Springs, United States Validation & Engineering Group Full time

We are seeking a skilled professional to join our team as a Computer Systems Validation Specialist in the biotechnology industry. As a member of our Validation and Engineering Group, you will play a critical role in ensuring that computerized systems related to manufacturing, laboratory, and quality control comply with regulatory standards.

About the Role

The ideal candidate will have a strong background in computer systems validation, particularly in the biotechnology industry. They will be responsible for designing and executing validation plans for computerized systems, conducting risk assessments, preparing and maintaining detailed documentation, overseeing testing and verification, and ensuring regulatory compliance.

This is an excellent opportunity for individuals who are passionate about validation and committed to delivering high-quality results. If you have a keen eye for detail, excellent analytical skills, and the ability to work independently, we encourage you to apply.

Key Responsibilities
  • Design and execute validation plans for computerized systems within biotech labs and manufacturing environments
  • Conduct risk assessments to prioritize system validation based on impact to patient safety, product quality, and regulatory compliance
  • Prepare and maintain detailed documentation for validation activities, including validation plans, test scripts, traceability matrices, and summary reports
  • Oversee the execution of validation tests, verifying that systems meet functional and compliance requirements
  • Ensure all computerized systems comply with biotechnology industry regulatory requirements, including FDA 21 CFR Part 11, GxP standards, and EMA guidelines
Requirements

To be successful in this role, you will need:

  • Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field
  • Minimum 3-5 years of experience in computer systems validation in the biotechnology or pharmaceutical industry
  • Strong knowledge of validation for LIMS, MES, and EBR systems in biotech environments
  • Familiarity with software development life cycle (SDLC) and validation lifecycle management
  • Excellent analytical thinking, attention to detail, and problem-solving skills
What We Offer

We offer a competitive salary of $85,000 per year, along with opportunities for career growth and professional development. Our team is dedicated to delivering high-quality services, and we are looking for like-minded individuals to join us. Apply now to take your career to the next level



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