CSV Engineer is a professional who specializes in working with CSV - Saline City, United States - Titan Industries

Titan Industries
Titan Industries
Verified Company
Saline City, United States

4 weeks ago

Meredith Sinclair

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Meredith Sinclair

beBee Recruiter
Description

As a CSV Engineer (m/f/x) for this exciting chemical and pharmaceutical company in Saline City, you will be responsible for supporting and optimizing processes within the CSV area. You will have the opportunity to contribute your own ideas and experiences.

These tasks await you:

  • Conducting computer system validations (planning, implementation, testing, and documentation of validation)
  • Creating risk assessments, user requirement specifications, IQ/OQ/PQ test scripts, and validation reports
  • Performing tests and documenting validation activities according to internal guidelines and regulatory requirements (e.g., FDA 21 CFR Part 11, GxP), including the creation of test protocols
  • Collaborating with internal and external partners, such as IT and quality management, to ensure efficient implementation of validation activities
  • Assisting in the equipment qualification of computerized systems
  • Conducting training on the validation and compliance of IT systems

Your profile should include:

  • Successfully completed studies in computer science, natural sciences, or similar fields
  • Thorough understanding of regulatory requirements in healthcare, including FDA guidelines, GxP standards, and other relevant regulations
  • Professional experience in the field of CSV in regulated life science environments, preferably with knowledge of LIMS
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