Sr. Computer Systems Validation Engineer
Company: Thermo Fisher Scientific
Posted on: February 15, 2019
Position Summary: Thermo Fisher Scientific is running a global program to roll out a corporate solution with software and harmonized processes for field Service management. To support the various businesses that will be using the system, the solution is validated to meet the compliance requirements of them businesses. The Sr. Validation Engineer role is responsible for the administrating all documentation and processes involved in maintaining the validated state through continuous change requests, application upgrades and with the addition of new businesses with new regulatory requirements to the solution. As the Service solution and the role is global, it requires someone that enjoys and supports all aspects that comes with a global role. Key Responsibilities:
- Supports and perform all technical writing aspects of Computer System Validation for the systems included in the Service solution
- Participate in the establishment of QA and Validation strategies, needs/requirements and associated plans in the development of the Service platform offering
- Review of release notes supporting vendor software releases for risk and impact assessment.
- Partner with IT, IT QA and Business teams in the development, implementation, project management, release, periodic review and maintenance of the Service Platform systems.
- Work by the Corporate IT processes for Computer System Validation and closely with Corporate IT QA for the development of the processes and related tools.
- Manage the System development life cycle for the validation. Coordinate and manages functional, user acceptance, validation and performance testing.
- Secure and qualify Quality Management system by monitoring compliance with procedures such as system access, change management, disaster recovery, back-ups; documentation.
- Helps preparing Functional and Technical specifications related to regulatory requirements Requirements/Qualifications:
- 5+ years' experience in a regulated environment including knowledge of GxP regulations with exhibited knowledge and proficiency of system validation and quality activities.
- Bachelor's Degree in Computer Science or equivalent combination of education and experience.
- Strong background in Quality Management Systems is strongly desirable including authoring, reviewing and approving of related processes and requirements.
- Demonstrate application experience with QMS related applications such as Master Control, TrackWise & 123 Compliance.
- Knowledge and experience with Agile system development.
- Experience with system support/system administration.
- Ability to drive multiple initiatives in a fast paced environment.
- Excellent analytical abilities, creative problem solving skills and strong planning and organizing capabilities.
- Ability to understand both the business and the technical aspects of the applications supported.
- Experience with validation, training, change management, CAPA, and/or supplier audits
- Ability to work well within a team environment.
- Strong in communication and documentation, ability to clearly communicate at all levels of the organization. Non-Negotiable Hiring Criteria:
- Bachelor's Degree in Computer Science or equivalent combination of education and experience
- Experience working in Quality Management Systems
- Experience working in a validated environment. Department: Information Technology - provided by Dice Agile, Change Management, Development, Disaster Recovery, Management, Performance Testing, Project, Project Management, QA, Release, Scientific, Technical Writing, Testing, UPS, Validation
Keywords: Thermo Fisher Scientific, San Diego , Sr. Computer Systems Validation Engineer, IT / Software / Systems , Carlsbad, California
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