Thermo Fisher Scientific South San Francisco, CA
About the Job
Validation Engineer, Computer Systems
Key Objectives of the Role:
- Lead the development, harmonization, 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
- Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk based validation approach for the system, working with key stakeholders to achieve business goals.
- 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
- 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
- Represent Validation in cross-functional team meetings/projects as required
- Effectively communicate with Leadership and all departments regarding Validation activities
- Organize and maintain validation documentation
- Apply Good Manufacturing Principles in all areas of responsibility
- Recommend acceptance of the computer system, as determined from the CSV tasks performed on the system.
- Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the team and wider business.
- Bachelor’s Degree in Engineering, Science, or related field
- Must have a minimum of 3-5 years experience in an FDA regulated industry
- Through knowledge of cGMP and FDA and EU Annex 11 regulations and standards
- Ability to impact and influence people/areas in matters related to CSV and GxP compliance
- Use of HPALM a plus
- Experience with Cloud compliance a plus