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Validation Engineer
Job Location:
Job Location:
San Diego, CA - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
24 October 2026 (9 hours ago)
Posted:
Application Deadline:
21 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Description: The Validation Engineer is responsible for using continuous improvement tools such as FMEA SolidWorks Root Cause Analysis SPC analysis PPAP APQP and process mapping.
Specifically this includes:
- Designing and Perform GAP Analysis and Risk Assessments Risk Management Plans and design CAPA remediation strategies.
-Compile analyze and interpret preliminary experimental results using Microsoft Excel and Minitab Statistical Software.
-ERP/MRP systems required related to Master data BOMs production workflows and related topics.
Provided internal training for QMS functions including organizational training and subject matter expertise for QMS compliance and process improvements test method and process validations (TMVs) for new instrumentation raw material properties and component qualifications. Maintained and used a variety of continuous improvement tools such as PPM reports FMEA and process mapping.
Specifically this includes:
- Identify the Risk of the Software.
- Research for Software user Requirements.
- Develop/ execute all the required equipment qualification documentation for the Equipment Validation
- Product compliance with industry specifications codes and equipment standards.
Software planning documents and other process documents for the entire Software development lifecycle SDLC toward conformance with applicable regulations and standards ensuring software quality (21 CFR 820.30 IEC/ISO -1 FDA guidance documents) and Regulatory strategy for EU MDD and create necessary regulatory pathway and training and implementation tools per EU MDR Article 120 requirements.
Specifically this includes:
- integration of complex suppliers processes materials data and technology to meet manufacturing and delivery requirements.
- Setting-up design and development process as per 21 CFR 820.30 & ISO13485
Validation deliverables Validation Master Plan (VMP) Validation Summary Documents (VSD) Validation Summary Reports (VSR) Installation Qualification/ Operational Qualification/ Performance Qualification and Requirements Traceability Matrix. Issues Log Incident Reports IQ Protocol/Report OQ Protocol/Report and Trace Matrix Develop and execute verification tests for client systems (i.e. medical software)
Specifically this includes:
- system inventory and assessment
-User requirement specifications
Executed informal and formal test procedures gathered appropriate data and document results identified defects provided input created solutions and verification of defect resolution. Testing cycle on UAT Integration Migration smoke and regression testing.
Specifically this includes:
- Software Test methodologies (Black Box White Box Unit Testing Software Integration and HW/SW Integration testing)
Required Qualification & Experience:This role requires the candidate to have at least a bachelors Degree or Higher in Computer Information Systems Computer Science or a closely related field.
Specifically this includes:
- Designing and Perform GAP Analysis and Risk Assessments Risk Management Plans and design CAPA remediation strategies.
-Compile analyze and interpret preliminary experimental results using Microsoft Excel and Minitab Statistical Software.
-ERP/MRP systems required related to Master data BOMs production workflows and related topics.
Provided internal training for QMS functions including organizational training and subject matter expertise for QMS compliance and process improvements test method and process validations (TMVs) for new instrumentation raw material properties and component qualifications. Maintained and used a variety of continuous improvement tools such as PPM reports FMEA and process mapping.
Specifically this includes:
- Identify the Risk of the Software.
- Research for Software user Requirements.
- Develop/ execute all the required equipment qualification documentation for the Equipment Validation
- Product compliance with industry specifications codes and equipment standards.
Software planning documents and other process documents for the entire Software development lifecycle SDLC toward conformance with applicable regulations and standards ensuring software quality (21 CFR 820.30 IEC/ISO -1 FDA guidance documents) and Regulatory strategy for EU MDD and create necessary regulatory pathway and training and implementation tools per EU MDR Article 120 requirements.
Specifically this includes:
- integration of complex suppliers processes materials data and technology to meet manufacturing and delivery requirements.
- Setting-up design and development process as per 21 CFR 820.30 & ISO13485
Validation deliverables Validation Master Plan (VMP) Validation Summary Documents (VSD) Validation Summary Reports (VSR) Installation Qualification/ Operational Qualification/ Performance Qualification and Requirements Traceability Matrix. Issues Log Incident Reports IQ Protocol/Report OQ Protocol/Report and Trace Matrix Develop and execute verification tests for client systems (i.e. medical software)
Specifically this includes:
- system inventory and assessment
-User requirement specifications
Executed informal and formal test procedures gathered appropriate data and document results identified defects provided input created solutions and verification of defect resolution. Testing cycle on UAT Integration Migration smoke and regression testing.
Specifically this includes:
- Software Test methodologies (Black Box White Box Unit Testing Software Integration and HW/SW Integration testing)
Required Qualification & Experience:This role requires the candidate to have at least a bachelors Degree or Higher in Computer Information Systems Computer Science or a closely related field.
Required Experience:
IC
About Company
Vastek Inc provides consulting, workforce solutions, and industry-specific delivery support across life sciences, healthcare, manufacturing, and technology.
