{"schemaVersion":"jobsearcher.job.v1","id":"54c800dfeff405fea8e62663","url":"https://jobsearcher.com/jobs/54c800dfeff405fea8e62663","canonicalUrl":"https://jobsearcher.com/jobs/54c800dfeff405fea8e62663","title":"6467 - Senior CSV Engineer / Senior Validation Engineer","description":"Description\nVerista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.\n\nOur ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.\n\nCompany Culture Guidelines & Values:\n\nWe empower and support our colleagues\n\nWe commit to client success at every turn\n\nWe have the courage to do the right thing\n\nWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.\n\nWe constantly acquire new skills and learn from our experiences to enhance our collective expertise\n\nJob Overview:\nWe are seeking a Senior CSV/CSA Engineer to lead validation activities for standalone, computerized bioprocess equipment being installed in a single-use manufacturing facility. The equipment will utilize UNICORN, KlariFi and Lucullus software and will not be integrated with the site DeltaV system. The engineer will own or lead the computer-system validation lifecycle while coordinating with Process Engineering, CQV, Automation, Quality, IT, equipment vendors and system owners.\n\nSenior Validation Engineer Responsibilities:\n\nDevelop and execute the CSV/CSA strategy for standalone GMP equipment systems\n\nReview equipment and software architecture, intended use and GxP impact\n\nAuthor or review validation plans, system assessments, risk assessments and supplier assessments\n\nReview URS, functional specifications, configuration specifications and design documentation\n\nDevelop and execute risk-based test protocols\n\nEvaluate vendor FAT, SAT, IQ and OQ documentation for leveraged testing\n\nTest user access, roles, permissions and account administration\n\nTest audit trails, electronic records and electronic signatures\n\nVerify recipe, method and configuration controls\n\nTest alarms, events, reports, data capture and record retention\n\nVerify backup, restoration, archival, time synchronization and disaster-recovery controls\n\nAssess compliance with 21 CFR Part 11, EU Annex 11 and applicable data-integrity requirements\n\nMaintain requirements traceability and validation-documentation packages\n\nManage discrepancies, deviations, corrective actions and validation-summary reporting\n\nSupport change control, SOP development, training and system release\n\nJob Requirements:\n\nBachelor’s degree in Engineering, Life Sciences, Computer Science or a related discipline\n\nApproximately seven or more years of CSV, CSA or computerized-equipment validation experience in a regulated life-sciences environment\n\nHands‑on experience validating standalone GMP manufacturing equipment\n\nStrong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5 and data‑integrity principles\n\nExperience testing access security, audit trails, electronic signatures, recipes, reports and computerized records\n\nAbility to review functional specifications, configuration specifications and system architecture\n\nStrong protocol authoring, execution and deviation‑management skills\n\nAbility to work independently with equipment vendors, engineers and Quality representatives\n\nDirect experience with UNICORN, KlariFi or Lucullus\n\nExperience with chromatography, tangential‑flow filtration or bioreactor systems\n\nExperience validating PLC/HMI‑or SCADA‑controlled equipment\n\nFamiliarity with Kneat or another electronic validation lifecycle system\n\nExperience supporting new‑equipment installation and capital‑project execution\n\nThis role requires the ability to be on‑site, full‑time in Devens, MA.\n\nSalary and Compensation (US)\nFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job‑related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.\n\n*Verista is an equal opportunity employer.\n\nNational (US) Range\n\n$80,465 — $131,685 USD\n\nBenefits\nWhy Choose Verista?\n\nHigh growth potential and fast‑paced organization with a people‑focused culture\n\nCompetitive pay plus performance‑based incentive programs\n\nCompany‑paid Life, Short‑Term, and Long‑Term Disability Insurance.\n\nMedical, Dental & Vision insurances\n\nFSA, DCARE, Commuter Benefits\n\nSupplemental Life, Hospital, Critical Illness and Legal Insurance\n\nHealth Savings Account\n\n401(k) Retirement Plan (Employer Matching benefit)\n\nPaid Time Off (Rollover Option) and Holidays\n\nAs Needed Sick Time\n\nTuition Reimbursement\n\nTeam Social Activities (We have fun!)\n\nEmployee Recognition\n\nEmployee Referral Program\n\nPaid Parental Leave and Bereavement\n\nVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.\n\nFor more information about our company, please visit us at Verista.com\n\n#J-18808-Ljbffr","company":"Socket","rawCompany":"socket","city":"Harvard","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-11T03:14:13.023Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"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":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"6467 - Senior CSV Engineer / Senior Validation Engineer","description":"Description\nVerista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.\n\nOur ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.\n\nCompany Culture Guidelines & Values:\n\nWe empower and support our colleagues\n\nWe commit to client success at every turn\n\nWe have the courage to do the right thing\n\nWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.\n\nWe constantly acquire new skills and learn from our experiences to enhance our collective expertise\n\nJob Overview:\nWe are seeking a Senior CSV/CSA Engineer to lead validation activities for standalone, computerized bioprocess equipment being installed in a single-use manufacturing facility. The equipment will utilize UNICORN, KlariFi and Lucullus software and will not be integrated with the site DeltaV system. The engineer will own or lead the computer-system validation lifecycle while coordinating with Process Engineering, CQV, Automation, Quality, IT, equipment vendors and system owners.\n\nSenior Validation Engineer Responsibilities:\n\nDevelop and execute the CSV/CSA strategy for standalone GMP equipment systems\n\nReview equipment and software architecture, intended use and GxP impact\n\nAuthor or review validation plans, system assessments, risk assessments and supplier assessments\n\nReview URS, functional specifications, configuration specifications and design documentation\n\nDevelop and execute risk-based test protocols\n\nEvaluate vendor FAT, SAT, IQ and OQ documentation for leveraged testing\n\nTest user access, roles, permissions and account administration\n\nTest audit trails, electronic records and electronic signatures\n\nVerify recipe, method and configuration controls\n\nTest alarms, events, reports, data capture and record retention\n\nVerify backup, restoration, archival, time synchronization and disaster-recovery controls\n\nAssess compliance with 21 CFR Part 11, EU Annex 11 and applicable data-integrity requirements\n\nMaintain requirements traceability and validation-documentation packages\n\nManage discrepancies, deviations, corrective actions and validation-summary reporting\n\nSupport change control, SOP development, training and system release\n\nJob Requirements:\n\nBachelor’s degree in Engineering, Life Sciences, Computer Science or a related discipline\n\nApproximately seven or more years of CSV, CSA or computerized-equipment validation experience in a regulated life-sciences environment\n\nHands‑on experience validating standalone GMP manufacturing equipment\n\nStrong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5 and data‑integrity principles\n\nExperience testing access security, audit trails, electronic signatures, recipes, reports and computerized records\n\nAbility to review functional specifications, configuration specifications and system architecture\n\nStrong protocol authoring, execution and deviation‑management skills\n\nAbility to work independently with equipment vendors, engineers and Quality representatives\n\nDirect experience with UNICORN, KlariFi or Lucullus\n\nExperience with chromatography, tangential‑flow filtration or bioreactor systems\n\nExperience validating PLC/HMI‑or SCADA‑controlled equipment\n\nFamiliarity with Kneat or another electronic validation lifecycle system\n\nExperience supporting new‑equipment installation and capital‑project execution\n\nThis role requires the ability to be on‑site, full‑time in Devens, MA.\n\nSalary and Compensation (US)\nFor US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job‑related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.\n\n*Verista is an equal opportunity employer.\n\nNational (US) Range\n\n$80,465 — $131,685 USD\n\nBenefits\nWhy Choose Verista?\n\nHigh growth potential and fast‑paced organization with a people‑focused culture\n\nCompetitive pay plus performance‑based incentive programs\n\nCompany‑paid Life, Short‑Term, and Long‑Term Disability Insurance.\n\nMedical, Dental & Vision insurances\n\nFSA, DCARE, Commuter Benefits\n\nSupplemental Life, Hospital, Critical Illness and Legal Insurance\n\nHealth Savings Account\n\n401(k) Retirement Plan (Employer Matching benefit)\n\nPaid Time Off (Rollover Option) and Holidays\n\nAs Needed Sick Time\n\nTuition Reimbursement\n\nTeam Social Activities (We have fun!)\n\nEmployee Recognition\n\nEmployee Referral Program\n\nPaid Parental Leave and Bereavement\n\nVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.\n\nFor more information about our company, please visit us at Verista.com\n\n#J-18808-Ljbffr","datePosted":"2026-08-11T03:14:13.023Z","dateModified":"2026-08-11T03:14:13.023Z","hiringOrganization":{"@type":"Organization","name":"Socket","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Harvard","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"54c800dfeff405fea8e62663"},"url":"https://jobsearcher.com/jobs/54c800dfeff405fea8e62663"}}