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Pharma Validation Engineer

Position Overview:
This position is responsible for IT computer systems validation with special focus on technology and applications development.
This position will be responsible for interpreting technology projects in the context of CSV, defining validation approach based on the nature of the project, creating and owning the relevant documentation and activity in alignment with both local and global CSV governance.
Roles & responsibilities:
  • Utilize this knowledge to define and control technology validation documentation.
  • Develop and manage project technical documentation for SDLC requirements during computer system implementation projects including developing validation approach, validation planning, technical system process flows, technical installation, development and verification documentation (IQ/OQ/PQ).
  • Work with applications development team to select methods and techniques for obtaining desirable solutions for each project and ensure compliance with regulations. Participate in relevant architecture, development code review meetings as necessary.
  • Conduct technology compliance assessments and audits for systems and processes owned by US IT Applications Development.
  • Participate in internal and external vendor audits relating to computerized systems.
Education Experience:
Bachelor's Degree or equivalent in Computer Information Systems, Management Information Systems, Engineering or related fields.
Training in Computer Systems Validation Competent in the use.
Job Type: Full-time