Computer Software Validation (CSV) Engineer

Job role- Computer Software Validation (CSV) Engineer

Location - Santa Clara, CA

Exp- 8+ years

Competencies : EIS : Medical Device & Regulations

• Plan, schedule and organize validation projects for new and existing applications from Manufacturing, Quality Control, Facilities, Clinical and Research and Development departments.
• Interact with various stakeholders to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects.
• Develop the Validation Strategy for the applications in compliance with required regulatory requirements pertaining to 21 CFR Part 11 and Annex 11.
• Author Validation Plan to document scope & purpose of validation project, roles and responsibilities, system description, intended use of the system, validation strategy, applicable regulatory framework, risk management, phases of the project, deliverables and RACI Matrix.
• Perform GxP Applicability and Criticality Assessment, Functional Risk Assessment and Audit Trail (System and Data) Risk Assessment.
• Draft, review and approval of Specifications (User Requirement Specification, Functional Specification, Design Specification, Configuration Specification) for application.
• Draft, review and approval of Qualification Protocols (Installation / Operational / Performance) for applications.
• Review and approval of executed Qualification Protocols (Installation / Operational / Performance) for applications.
• Author Traceability Matrix document to include the traceability of User Requirements, Functional Requirements, Design / Configuration Specifications and Qualification Protocol.
• Author Validation / Qualification Summary Reports to present, summarize and offer conclusions on the validation of the process based on the results of the results of Validation / Qualification efforts
• Author, review and approval of deviation reports, exceptions and non-conformance reports.
• Prepare, revise and implement relevant SOPs related to the QMS.
• Effectively communicate with other departments on quality and compliance issues.
• Participate in vendor, internal and regulatory audits.
• Participate in and lead quality and process improvement projects.
• Develop and conduct annual QMS and regulatory training
• Properly interpret and apply regulatory requirements.
• Ensure all SOPs, Forms, and Policies are in compliance with internal documentation rules and Periodic Review procedures.

Competencies : EIS : Medical Device & Regulations

Essential Skills :

Senior Computer Software Validation (CSV) Engineer A Minimum Bachelors Degree in Engineering, Computer Science or related technical field

Desirable Skills :

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.