{"schemaVersion":"jobsearcher.job.v1","id":"f087db4036df847db3b3336a","url":"https://jobsearcher.com/jobs/f087db4036df847db3b3336a","canonicalUrl":"https://jobsearcher.com/jobs/f087db4036df847db3b3336a","title":"Computer system validation engineer","description":"Job Title: Computer System Validation EngineerLocation: Bothell, WADuration: 12 months on W2Job SummaryWe are seeking a Computer System Validation Engineer to support validation activities for GxP electronic systems and Manufacturing Execution Systems (MES) within a GMP manufacturing environment. The selected candidate will work cross-functionally with Business Owners, Technical Owners, and Quality teams to create, manage, and execute validation deliverables throughout the system validation lifecycle.Key Responsibilities• Author, review, and approve applicable Computer System Validation (CSV) documentation.• Develop, review, and execute validation protocols and test scripts.• Support IQ, OQ, PQ, or equivalent testing activities.• Assist Business Owners and Technical Owners with requirements and specifications for computerized systems used in GxP operations.• Execute testing, document test failures, support deviation investigations, and ensure testing aligns with internal procedures and regulatory requirements.• Prepare and maintain validation deliverables, including:o Validation Planso User and Functional Requirementso System and Functional Specificationso Validation Assessmentso Test Scripts and Protocolso Traceability Matriceso Summary Reportso SOPs and related documentation• Support validation activities for MES and other computerized systems.• Ensure validation tasks are properly documented in accordance with applicable company procedures, GMP requirements, and regulatory expectations.• Perform additional validation-related duties as assigned.Required Qualifications• At least 3 years of Computer System Validation (CSV) experience; 4 years preferred.• Strong experience with CSV documentation, protocol development, and test execution.• GMP manufacturing experience.• Familiarity with Manufacturing Execution Systems (MES).• Strong understanding of validation lifecycle processes and regulatory documentation.• Ability to work onsite and follow the required shift schedule.• Strong written and verbal communication skills.• Ability to manage projects and validation activities independently.• Bachelor’s degree in Life Sciences, Engineering, Information Technology, or equivalent industry experience.Preferred Qualifications• Experience with MES platforms such as Emerson Syncade.• Familiarity with ERP systems such as SAP or Oracle.• Experience with Electronic Batch Records (EBRs), such as InfoBatch.• Experience working in cleanroom or GMP-regulated manufacturing environments.• Knowledge of Good Manufacturing Practices and standard operating procedures.Top Required Skills1. Strong Computer System Validation (CSV) experience2. MES familiarity and validation experience3. Protocol drafting and execution4. GMP manufacturing experience5. Strong communication and self-project management skillsEEO Statement:Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.","company":"Mindlance","rawCompany":"mindlance","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-09-11T09:15:36.919Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"334111","title":"Electronic Computer Manufacturing","slug":"electronic-computer-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer system validation engineer","description":"Job Title: Computer System Validation EngineerLocation: Bothell, WADuration: 12 months on W2Job SummaryWe are seeking a Computer System Validation Engineer to support validation activities for GxP electronic systems and Manufacturing Execution Systems (MES) within a GMP manufacturing environment. The selected candidate will work cross-functionally with Business Owners, Technical Owners, and Quality teams to create, manage, and execute validation deliverables throughout the system validation lifecycle.Key Responsibilities• Author, review, and approve applicable Computer System Validation (CSV) documentation.• Develop, review, and execute validation protocols and test scripts.• Support IQ, OQ, PQ, or equivalent testing activities.• Assist Business Owners and Technical Owners with requirements and specifications for computerized systems used in GxP operations.• Execute testing, document test failures, support deviation investigations, and ensure testing aligns with internal procedures and regulatory requirements.• Prepare and maintain validation deliverables, including:o Validation Planso User and Functional Requirementso System and Functional Specificationso Validation Assessmentso Test Scripts and Protocolso Traceability Matriceso Summary Reportso SOPs and related documentation• Support validation activities for MES and other computerized systems.• Ensure validation tasks are properly documented in accordance with applicable company procedures, GMP requirements, and regulatory expectations.• Perform additional validation-related duties as assigned.Required Qualifications• At least 3 years of Computer System Validation (CSV) experience; 4 years preferred.• Strong experience with CSV documentation, protocol development, and test execution.• GMP manufacturing experience.• Familiarity with Manufacturing Execution Systems (MES).• Strong understanding of validation lifecycle processes and regulatory documentation.• Ability to work onsite and follow the required shift schedule.• Strong written and verbal communication skills.• Ability to manage projects and validation activities independently.• Bachelor’s degree in Life Sciences, Engineering, Information Technology, or equivalent industry experience.Preferred Qualifications• Experience with MES platforms such as Emerson Syncade.• Familiarity with ERP systems such as SAP or Oracle.• Experience with Electronic Batch Records (EBRs), such as InfoBatch.• Experience working in cleanroom or GMP-regulated manufacturing environments.• Knowledge of Good Manufacturing Practices and standard operating procedures.Top Required Skills1. Strong Computer System Validation (CSV) experience2. MES familiarity and validation experience3. Protocol drafting and execution4. GMP manufacturing experience5. Strong communication and self-project management skillsEEO Statement:Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.","datePosted":"2026-09-11T09:15:36.919Z","dateModified":"2026-09-11T09:15:36.919Z","hiringOrganization":{"@type":"Organization","name":"Mindlance","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f087db4036df847db3b3336a"},"url":"https://jobsearcher.com/jobs/f087db4036df847db3b3336a"}}