{"schemaVersion":"jobsearcher.job.v1","id":"64973fe4b5c9fe68ce91f9cf","url":"https://jobsearcher.com/jobs/64973fe4b5c9fe68ce91f9cf","canonicalUrl":"https://jobsearcher.com/jobs/64973fe4b5c9fe68ce91f9cf","title":"Validation Engineer (CQV)","description":"Job Description\n\nValspec—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.Valspec'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.Validation Engineer (CQV)Location: Raleigh-Durham area, NCPosition OverviewWe are seeking an experienced Validation Engineer (CQV) to support commissioning, qualification, and startup activities for a large-scale biopharmaceutical manufacturing facility. This role will focus on downstream process systems and requires strong hands-on field execution, system troubleshooting, and automation verification experience in a GMP-regulated environment.Key ResponsibilitiesPerform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, and utility connections to confirm system accuracy and readiness ahead of commissioning and startup.Lead and execute mechanical completion walkdowns and turnover package (TOP) reviews, ensuring construction quality, punch list closure, calibration records, weld documentation, and redline updates are complete.Support commissioning readiness by validating system boundaries, flow paths, and equipment installation in alignment with design documentation.Execute commissioning and qualification (CQV) activities for downstream process equipment including:Chromatography skidsUltrafiltration/Diafiltration (UF/DF) systemsViral filtration systemsDepth filtration unitsBuffer preparation vesselsProduct hold tanksPerform field startup and functional testing of chromatography systems, including:Flow path verificationValve sequencing checksConductivity and pressure monitoringAutomation functionality validationConduct Operational Qualification (OQ) testing for automated systems using DeltaV, including:Loop checks and I/O verificationInterlock and permissive testingAlarm challenge testingControl logic and sequence verification under live conditionsVerify process alarms, interlocks, permissives, and emergency shutdown functions through field execution and control system testing.Perform detailed P&ID walkdowns and field verification of valves, instruments, and process flow to support system turnover, TOP approval, and final acceptance.Identify and troubleshoot startup issues related to:Automation logic and control sequencesValve sequencing and flow path discrepanciesEquipment integration and skid interfacesCleaning cycle performanceCollaborate cross-functionally with engineering, construction, and operations teams to maintain project timelines and ensure successful system startup.Required QualificationsBachelor's degree in Engineering (Chemical, Mechanical, or related discipline) or equivalent industry experience5+ years of experience in CQV, commissioning, or validation within biopharmaceutical or life sciences manufacturingHands-on experience with downstream processing equipment, especially chromatography and filtration systemsStrong knowledge of cGMP requirements, commissioning processes, and validation lifecycleExperience executing OQ protocols and field testing activitiesFamiliarity with DeltaV or similar DCS platforms (Emerson experience preferred)Proficiency in reading and interpreting P&IDs, isometrics, and technical drawingsDemonstrated ability to work in a fast-paced startup environment with significant field presencePreferred QualificationsPrevious experience supporting greenfield or large-scale capital projectsStrong troubleshooting and problem-solving skills in live plant environmentsExperience with automation systems integration and process control verificationAbility to manage multiple systems and priorities during commissioning/startup phasesWork EnvironmentPrimarily field-based role with significant time in manufacturing and construction areasRequires coordination with multiple stakeholders across CQV, engineering, and operationsMay involve extended hours during critical commissioning and startup windowsWhy Join Valspec?At 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.Join a team where your contributions matter, your development is prioritized, and your success is shared.Why Join Valspec?At 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:Premium medical coverage401(k) with company matchTuition reimbursementUnique performance incentivesAnd more — all designed to support your growth, well-being, and future.Join a team where your contributions matter, your development is prioritized, and your success is shared.When 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.Candidates 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.Any 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.Valspec 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":"Oceanside","state":"CA","isRemote":false,"isActive":true,"createdAt":"2026-07-27T23:57:36.824Z","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":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer (CQV)","description":"Job Description\n\nValspec—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.Valspec'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.Validation Engineer (CQV)Location: Raleigh-Durham area, NCPosition OverviewWe are seeking an experienced Validation Engineer (CQV) to support commissioning, qualification, and startup activities for a large-scale biopharmaceutical manufacturing facility. This role will focus on downstream process systems and requires strong hands-on field execution, system troubleshooting, and automation verification experience in a GMP-regulated environment.Key ResponsibilitiesPerform field verification of P&IDs, equipment datasheets, vendor drawings, isometrics, and utility connections to confirm system accuracy and readiness ahead of commissioning and startup.Lead and execute mechanical completion walkdowns and turnover package (TOP) reviews, ensuring construction quality, punch list closure, calibration records, weld documentation, and redline updates are complete.Support commissioning readiness by validating system boundaries, flow paths, and equipment installation in alignment with design documentation.Execute commissioning and qualification (CQV) activities for downstream process equipment including:Chromatography skidsUltrafiltration/Diafiltration (UF/DF) systemsViral filtration systemsDepth filtration unitsBuffer preparation vesselsProduct hold tanksPerform field startup and functional testing of chromatography systems, including:Flow path verificationValve sequencing checksConductivity and pressure monitoringAutomation functionality validationConduct Operational Qualification (OQ) testing for automated systems using DeltaV, including:Loop checks and I/O verificationInterlock and permissive testingAlarm challenge testingControl logic and sequence verification under live conditionsVerify process alarms, interlocks, permissives, and emergency shutdown functions through field execution and control system testing.Perform detailed P&ID walkdowns and field verification of valves, instruments, and process flow to support system turnover, TOP approval, and final acceptance.Identify and troubleshoot startup issues related to:Automation logic and control sequencesValve sequencing and flow path discrepanciesEquipment integration and skid interfacesCleaning cycle performanceCollaborate cross-functionally with engineering, construction, and operations teams to maintain project timelines and ensure successful system startup.Required QualificationsBachelor's degree in Engineering (Chemical, Mechanical, or related discipline) or equivalent industry experience5+ years of experience in CQV, commissioning, or validation within biopharmaceutical or life sciences manufacturingHands-on experience with downstream processing equipment, especially chromatography and filtration systemsStrong knowledge of cGMP requirements, commissioning processes, and validation lifecycleExperience executing OQ protocols and field testing activitiesFamiliarity with DeltaV or similar DCS platforms (Emerson experience preferred)Proficiency in reading and interpreting P&IDs, isometrics, and technical drawingsDemonstrated ability to work in a fast-paced startup environment with significant field presencePreferred QualificationsPrevious experience supporting greenfield or large-scale capital projectsStrong troubleshooting and problem-solving skills in live plant environmentsExperience with automation systems integration and process control verificationAbility to manage multiple systems and priorities during commissioning/startup phasesWork EnvironmentPrimarily field-based role with significant time in manufacturing and construction areasRequires coordination with multiple stakeholders across CQV, engineering, and operationsMay involve extended hours during critical commissioning and startup windowsWhy Join Valspec?At 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.Join a team where your contributions matter, your development is prioritized, and your success is shared.Why Join Valspec?At 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:Premium medical coverage401(k) with company matchTuition reimbursementUnique performance incentivesAnd more — all designed to support your growth, well-being, and future.Join a team where your contributions matter, your development is prioritized, and your success is shared.When 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.Candidates 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.Any 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.Valspec 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":"2026-07-27T23:57:36.824Z","dateModified":"2026-07-27T23:57:36.824Z","hiringOrganization":{"@type":"Organization","name":"Valspec","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Oceanside","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"64973fe4b5c9fe68ce91f9cf"},"url":"https://jobsearcher.com/jobs/64973fe4b5c9fe68ce91f9cf"}}