Computer Systems Validation Analyst

Thermo Fisher Scientific-Budapest, Hungary

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Are you ready to take your career to the next level? Thermo Fisher Scientific Inc. is seeking a Systems Analyst III - CSV to join our world-class team in Budapest. As part of our ambitious and collaborative IT department, you will have the opportunity to make an exceptional impact on our organization.

Responsibilities:

  • Determine and document user requirements for computer systems
  • Develop and implement software validation plans and protocols
  • Collaborate with diverse teams to ensure detailed execution of computer system validation activities.
  • Conduct risk assessments to identify potential issues and develop mitigation strategies
  • Perform data analysis and generate reports to support decision-making processes
  • Support with Deviations, CAPA, drafting and approving deviation logs and keeping artifacts audit ready in MasterControl, ALM and Service Now tools. A sound knowledge of SAP, EDMS/QMS systems like MasterControl, HP ALM, Documentum and CHG Management tool Service Now is preferred.
  • Review and draft standard operating procedures for tools refresh, upgrades, patching etc.
  • Coordinating with partners for configuration and design specs update and overall system CHG management.

Requirements:

  • Bachelor's degree in Computer Science or a related field, or equivalent experience.
  • Demonstrated expertise in computer system validation within the pharmaceutical industry
  • Strong analytical and problem-solving skills
  • Strong interpersonal skills for effective collaboration
  • Strong commitment to meeting regulatory requirements and industry standards