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Job ID :
42222BR
Location :
US - California - Carlsbad
:
Job Description
** This position does not offer relocation. Applicants need to be willing and able to relocate on their own expense**

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.


Key Objectives of the Role:
  • Participate in the development, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
  • Preparation, review and issuing of CSV documents as they related to computer systems:
  • Author, execute, perform, summarize CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling
  • Identify computerized systems validation needs through assessments and integration with IT Project Management Framework.
  • Support change control activities, deviations and SOP’s for computer systems
  • Review and approve the relevant documents on validation processes
  • Ensure that the Validation / Qualification and quality systems are working in accordance with any changing and current regulations.
  • Participate in the development of Validation methodologies in accordance with applicable Quality/Regulatory requirements and industry best practices
  • Work closely with IT, Business, Regulatory Affairs, and Quality to develop, coordinate and execute Validation documents and strategies
  • Manage and execute decommissioning activities for retired or end-of-life equipment
  • Author/revise SOPs related to validation/qualification, operations, IT, as they relate to CSV
  • Represent Validation in cross-functional team meetings/projects as required
  • Effectively communicate with Leadership and all departments regarding Validation activities
  • Participate in conducting root cause analysis, deviation resolution (CAPA), and effectiveness checks for CSV
  • Organize and maintain validation documentation
  • Apply Good Manufacturing Principles in all areas of responsibility
  • Play an integral role in Practical Process Improvement (PPI) program
  • Recommend acceptance of the computer system, as determined from the CSV tasks performed on the system.
  • Analyze data outputs from CSV activities in order to determine acceptability of system for GxP business use. Recommends actions to be taken if the software is not accepted.
Minimum Qualifications:
  • Bachelor’s Degree in Engineering, Science, or related field
  • Must have a minimum of 6-8 years experience in an FDA regulated industry
  • Experience in a manufacturing or R&D operation a plus
  • Through knowledge of cGMP and FDA regulations and Annex 11
  • Ability to impact and influence people/areas in matters related to CSV and GxP compliance




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.
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