Thermo Fisher Scientific Senior Validation Engineer in San Jose, California

Job Description

This position will support manufacturing and other functional groups in the validation of software, processes, equipment and other systems for process improvement and compliance to regulations and standards as applicable. This includes, but is not limited to: IT, QA, Document Control, Manufacturing, development tools qualification and the Quality Management System (QMS). The individual needs to be able to understand the processes described and assist the business process owners in preparing the appropriate validation strategy and documentation required.

Key Responsibilities:

  • Identify issues requiring validation support and work closely with Manufacturing Engineering, Operations and other business process owners to develop process, software, spreadsheet, dbase and utility validation strategy, plans, requirements, protocols and reports and related validation documentation

  • Maintain validation documentation and records (Operating Procedures and/or Work Instructions and forms/templates, etc.) for compliance to requirements

  • Conduct risk analysis, pFMEAs and other risk processes for validations and associated processes as appropriate including maintenance of the validation risk register

  • Conduct data analysis to determine appropriate sample plans and conduct statistical review of validation results using appropriate tools such as GR&R, six sigma and capability analysis

  • Interface with Document Control and respond to change configurations issues regarding ECO/EDAs/FAs that impact process/software validation status

  • Provide expertise in application of regulations and standards that apply to validation, i.e. QSR, 13485, 9001, 14971

  • Maintain Site VMP, Validation Life Cycle, schedule, validation database tracking and status reports

  • Train and mentor others on validation approach, strategy, implementation and documentation

  • Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support, and approval for identified validation projects

  • Must have excellent written and verbal communication skills with ability to brief business process owners, stakeholders and leadership

  • Interface with management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support, and approval for identified validation projects

  • Other responsibilities as assigned

Minimum Requirements/Qualifications:

  • Bachelor’s degree in Engineering or Sciences, or equivalent work experience required

  • 5 - 8 years validation experience within any environment

  • Must be a self-starter and driver of projects

  • Must be team oriented and have excellent interpersonal skills

  • Must have creative problem-solving skills and be comfortable with ambiguity

  • Must be practical, flexible and effectively work in a risk-based validation environment

This position has not been approved for Relocation Assistance.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.