{"schemaVersion":"jobsearcher.job.v1","id":"54668825984c60fd5917d43a","url":"https://jobsearcher.com/jobs/54668825984c60fd5917d43a","canonicalUrl":"https://jobsearcher.com/jobs/54668825984c60fd5917d43a","title":"Computer System Validation Engineer","description":"Job Title: Computer System Validation EngineerLocation: Bothell, WA 98021 /HybridDuration: 12 Months (possible extension)Pay Rate starting at $70/hr on w2.Top SkillsStrong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.Job DescriptionPurpose and Scope of Position:The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.The CSV Contractor has primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant client’s procedures and regulations.This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.Duties And ResponsibilitiesLead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.Author, review and/or approve applicable CSV documentationAssist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal proceduresAssist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operationsSupport health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required)Other related duties as assigned.Required Competencies: Knowledge, Skills, and Abilities:Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)Ability to effectively communicate with both technical and non-technical team members.Strong interpersonal skills, especially regarding team work, client focus, verbal and written communicationKnowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).Strong technical and problem-solving skills and the ability to work independently.Demonstrated success working in a high-performing, business results-driven environment.Education And ExperienceBachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.Must have experience with Computer system validation of MES.Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.comBenefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com .LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.","company":"Spectraforce","rawCompany":"spectraforce","city":"Bothell","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-04-12T16:36:23.835Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"15-1211.00","title":"Computer Systems Analysts","slug":"computer-systems-analysts"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"}],"industries":[{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer System Validation Engineer","description":"Job Title: Computer System Validation EngineerLocation: Bothell, WA 98021 /HybridDuration: 12 Months (possible extension)Pay Rate starting at $70/hr on w2.Top SkillsStrong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.Job DescriptionPurpose and Scope of Position:The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.This role is an individual contributor. The CSV Contractor will partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.The CSV Contractor has primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant client’s procedures and regulations.This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.Duties And ResponsibilitiesLead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.Author, review and/or approve applicable CSV documentationAssist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal proceduresAssist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operationsSupport health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required)Other related duties as assigned.Required Competencies: Knowledge, Skills, and Abilities:Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)Ability to effectively communicate with both technical and non-technical team members.Strong interpersonal skills, especially regarding team work, client focus, verbal and written communicationKnowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).Strong technical and problem-solving skills and the ability to work independently.Demonstrated success working in a high-performing, business results-driven environment.Education And ExperienceBachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.Must have experience with Computer system validation of MES.Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.comBenefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com .LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.","datePosted":"2026-04-12T16:36:23.835Z","dateModified":"2026-04-12T16:36:23.835Z","hiringOrganization":{"@type":"Organization","name":"Spectraforce","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bothell","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"54668825984c60fd5917d43a"},"url":"https://jobsearcher.com/jobs/54668825984c60fd5917d43a"}}