{"schemaVersion":"jobsearcher.job.v1","id":"cf0af42d3d34d20ac690ba7f","url":"https://jobsearcher.com/jobs/cf0af42d3d34d20ac690ba7f","canonicalUrl":"https://jobsearcher.com/jobs/cf0af42d3d34d20ac690ba7f","title":"Validation Engineer (CSV)","description":"Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.\nValspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.\nLead Validation Engineer (CSV / DeltaV)\nValspec | Seattle, WA\nFull-Time | Hybrid Client Site Support\nAbout Valspec\nValspec, part of the Proconex family of companies, is a leading provider of Computer System Validation (CSV), Computer Software Assurance (CSA), Commissioning & Qualification (CQV), and manufacturing systems consulting services for the life sciences industry. Valspec partners with pharmaceutical and biotechnology manufacturers to deliver compliant, reliable, and efficient systems throughout the project lifecycle.\nPosition Summary\nValspec is seeking a Lead Validation Engineer (CSV/DeltaV) to support a major biologics manufacturing operation in the Seattle area.\nThis role is ideal for a senior validation professional with extensive DeltaV experience and a proven track record leading validation activities within GMP-regulated pharmaceutical and biotechnology facilities. The successful candidate will provide technical leadership for computerized system validation efforts, support project execution, and work closely with Automation, Engineering, Manufacturing, Quality, and IT teams to ensure compliant system implementation and operation. The role includes both strategic validation planning and hands-on protocol development and execution.\nKey Responsibilities\nLead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems.\nDevelop and execute validation deliverables including:\nValidation Plans\nRisk Assessments\nRequirements Traceability Matrices (RTMs)\nInstallation & Operational Qualification Protocols (IQ/OQ/IOQ)\nValidation Summary Reports\nSupport DeltaV system implementations, upgrades, expansions, and modifications.\nReview and approve engineering documentation, functional specifications, design specifications, and configuration documentation.\nCoordinate validation activities across Automation, Engineering, Manufacturing, IT, and Quality organizations.\nLead protocol execution, deviation investigations, issue resolution, and documentation closeout.\nSupport change control activities and validation impact assessments.\nProvide technical guidance and mentorship to junior validation engineers.\nDrive risk-based validation and software assurance practices aligned with current industry expectations.\nSupport startup, commissioning, qualification, and operational readiness activities.\nParticipate in project planning, scheduling, resource coordination, and stakeholder communications.\nRequired Qualifications\nBachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.\n8+ years of Computer System Validation experience within a GMP-regulated pharmaceutical or biotechnology environment.\nHands-on DeltaV validation experience is required.\nExperience leading validation projects and coordinating cross-functional teams.\nProven experience developing and executing:\nValidation Plans\nRisk Assessments\nRTMs\nIQ/OQ Protocols\nValidation Summary Reports\nStrong knowledge of:\nGAMP 5\nCSA and CSV methodologies\n21 CFR Part 11\nData Integrity principles\nGMP documentation practices\nExcellent technical writing, communication, and client-facing skills.\nPreferred Qualifications\nDeltaV Batch experience.\nExperience supporting biologics or pharmaceutical manufacturing facilities.\nExperience with:\nMES platforms\nManufacturing automation systems\nInfrastructure qualification\nCommissioning & Qualification activities\nConsulting experience within regulated life sciences environments.\nPrevious experience serving as a Validation Lead or Project Lead.\n\nWhy Join Valspec?\nAt Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:\nPremium medical coverage\n401(k) with company match\nTuition reimbursement\nUnique performance incentives\nAnd more — all designed to support your growth, well-being, and future.\nJoin a team where your contributions matter, your development is prioritized, and your success is shared.\nWhen receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.\nCandidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.\nAny third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.\nValspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.","company":"Valspec","rawCompany":"valspec","city":"Redmond","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-08-04T23:27:32.266Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"15-1299.08","title":"Computer Systems Engineers/Architects","slug":"computer-systems-engineers-architects"}],"industries":[{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer (CSV)","description":"Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.\nValspec's projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.\nLead Validation Engineer (CSV / DeltaV)\nValspec | Seattle, WA\nFull-Time | Hybrid Client Site Support\nAbout Valspec\nValspec, part of the Proconex family of companies, is a leading provider of Computer System Validation (CSV), Computer Software Assurance (CSA), Commissioning & Qualification (CQV), and manufacturing systems consulting services for the life sciences industry. Valspec partners with pharmaceutical and biotechnology manufacturers to deliver compliant, reliable, and efficient systems throughout the project lifecycle.\nPosition Summary\nValspec is seeking a Lead Validation Engineer (CSV/DeltaV) to support a major biologics manufacturing operation in the Seattle area.\nThis role is ideal for a senior validation professional with extensive DeltaV experience and a proven track record leading validation activities within GMP-regulated pharmaceutical and biotechnology facilities. The successful candidate will provide technical leadership for computerized system validation efforts, support project execution, and work closely with Automation, Engineering, Manufacturing, Quality, and IT teams to ensure compliant system implementation and operation. The role includes both strategic validation planning and hands-on protocol development and execution.\nKey Responsibilities\nLead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems.\nDevelop and execute validation deliverables including:\nValidation Plans\nRisk Assessments\nRequirements Traceability Matrices (RTMs)\nInstallation & Operational Qualification Protocols (IQ/OQ/IOQ)\nValidation Summary Reports\nSupport DeltaV system implementations, upgrades, expansions, and modifications.\nReview and approve engineering documentation, functional specifications, design specifications, and configuration documentation.\nCoordinate validation activities across Automation, Engineering, Manufacturing, IT, and Quality organizations.\nLead protocol execution, deviation investigations, issue resolution, and documentation closeout.\nSupport change control activities and validation impact assessments.\nProvide technical guidance and mentorship to junior validation engineers.\nDrive risk-based validation and software assurance practices aligned with current industry expectations.\nSupport startup, commissioning, qualification, and operational readiness activities.\nParticipate in project planning, scheduling, resource coordination, and stakeholder communications.\nRequired Qualifications\nBachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.\n8+ years of Computer System Validation experience within a GMP-regulated pharmaceutical or biotechnology environment.\nHands-on DeltaV validation experience is required.\nExperience leading validation projects and coordinating cross-functional teams.\nProven experience developing and executing:\nValidation Plans\nRisk Assessments\nRTMs\nIQ/OQ Protocols\nValidation Summary Reports\nStrong knowledge of:\nGAMP 5\nCSA and CSV methodologies\n21 CFR Part 11\nData Integrity principles\nGMP documentation practices\nExcellent technical writing, communication, and client-facing skills.\nPreferred Qualifications\nDeltaV Batch experience.\nExperience supporting biologics or pharmaceutical manufacturing facilities.\nExperience with:\nMES platforms\nManufacturing automation systems\nInfrastructure qualification\nCommissioning & Qualification activities\nConsulting experience within regulated life sciences environments.\nPrevious experience serving as a Validation Lead or Project Lead.\n\nWhy Join Valspec?\nAt Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:\nPremium medical coverage\n401(k) with company match\nTuition reimbursement\nUnique performance incentives\nAnd more — all designed to support your growth, well-being, and future.\nJoin a team where your contributions matter, your development is prioritized, and your success is shared.\nWhen receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored.\nCandidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time.\nAny third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.\nValspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.","datePosted":"2026-08-04T23:27:32.266Z","dateModified":"2026-08-04T23:27:32.266Z","hiringOrganization":{"@type":"Organization","name":"Valspec","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Redmond","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"cf0af42d3d34d20ac690ba7f"},"url":"https://jobsearcher.com/jobs/cf0af42d3d34d20ac690ba7f"}}