Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

What sets this opportunity apart

At Thermo Fisher Scientific, we offer a highly dynamic work environment where your contributions can have a significant impact. As a Systems Analyst II - CSV, you will be part of a team that values collaboration, innovation, and excellence. You will have the opportunity to work with brand new technologies and be involved in projects that drive technological innovation and support critical scientific research.

Key Responsibilities

Coordinate and help with computer systems assessment for GxP regulatory applicability and risk assessments.Determine and document user requirements for computer systems.Develop and implement flawless 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 proven 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.Review and approve Change controls for system enhancements, modifications, break-fixes, tools refresh, upgrades and patchingCoordinate with partners for configuration and design specs updates 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 dedication to meeting regulatory requirements and industry standards.