CSV Validation Specialist

2 days ago


Akron, Ohio, United States Omni Inclusive Full time
Job Summary

We are seeking a highly skilled CSV Validation Specialist to join our team at Omni Inclusive. As a CSV Validation Specialist, you will be responsible for ensuring the successful implementation of manufacturing and laboratory equipment, and computerized systems at multi-use sites.

You will contribute to the completion of milestones associated with equipment qualification and systems validation, and use your analytical skills to recognize and solve common problems of limited scope.

This is a fantastic opportunity to work with a talented team and contribute to the success of our organization.

Key Responsibilities
  • Develop and execute equipment qualification and validation protocols
  • Support the execution of equipment qualifications and validation protocols
  • Configure and document the configuration of computerized systems
  • Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and Change Controls
  • Manage projects of varying scope and complexity
Requirements
  • BS degree in Engineering or Computer Science
  • Minimum 5 years of experience in FDA-regulated industry, with min 3 years' experience in CSV
  • Strong working knowledge of MS Windows client and server technologies
  • Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

Our team is passionate about delivering high-quality results and making a positive impact on our organization.

We are committed to creating a positive and inclusive work environment, and we welcome applications from diverse candidates.


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