{"schemaVersion":"jobsearcher.job.v1","id":"b69936f5beab73f3ab429022","url":"https://jobsearcher.com/jobs/b69936f5beab73f3ab429022","canonicalUrl":"https://jobsearcher.com/jobs/b69936f5beab73f3ab429022","title":"QC Lifecycle Validation Engineer","description":"NO C2C\nJob Description: QC Lifecycle Validation Engineer\nDevens, MA\nHybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)\nResponsibilities will include (but not limited to):\nAct as the project lead for qualification of QC equipment and its associated software\nDesign, execute, manage, and implement QC instrument/software qualification documents such as (but not\nlimited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ\nprotocols, software test scripts, configuration specifications, risk assessments, qualification summary reports\nAuthor/execute computer system validation scripts using an electronic validation database (ALM) or paper based\nas required.\nOwn change controls specific to the qualification of QC instruments and its associated software\nUpdate the asset management database to reflect new assets, calibrations, preventative maintenances\nAuthor instrument operational SOPs as needed\nCoordinate/interface/host vendors on site\nChampions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive\nActions (CA/Client)\nActs as the liaison between Digital Plant (IT) and lab departments\nEducation, Qualifications and Experience Required:\nBachelor’s degree in relevant scientific, engineering, or computer-based area with 5 – 7 years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.\nQuality management system experience including document control/management, change controls,\ninvestigations, deviations, electronic validation databases, asset management database\nKnowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery\nIncumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects\nDemonstrated success in cross functional influencing, strong communication, and collaboration skills\nWorking knowledge of laboratory systems such as Empower, NuGenesis and other software programs, including\nMicrosoft Office Applications, preferred.\nMust have equipment validation experience\nMust have GMP experience\nMust have Quality Management System (QMS) experience\nExperience in Computer System Validation is a plus.\nExperience in any asset management software is a plus.\nJob Type: Contract\nPay: $60.00 - $65.00 per hour\nSchedule:\n8 hour shift\nMonday to Friday\nAbility to commute/relocate:\nDevens, MA 01434: Reliably commute or planning to relocate before starting work (Required)\nExperience:\nPharmaceutical: 5 years (Required)\nLaboratory Qualification: 5 years (Required)\nChange Controls/Deviations and CAPAs.: 5 years (Required)\nWork Location: In person","company":"Eclaro","rawCompany":"eclaro","city":"Devens","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-06T11:27:39.742Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"QC Lifecycle Validation Engineer","description":"NO C2C\nJob Description: QC Lifecycle Validation Engineer\nDevens, MA\nHybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)\nResponsibilities will include (but not limited to):\nAct as the project lead for qualification of QC equipment and its associated software\nDesign, execute, manage, and implement QC instrument/software qualification documents such as (but not\nlimited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ\nprotocols, software test scripts, configuration specifications, risk assessments, qualification summary reports\nAuthor/execute computer system validation scripts using an electronic validation database (ALM) or paper based\nas required.\nOwn change controls specific to the qualification of QC instruments and its associated software\nUpdate the asset management database to reflect new assets, calibrations, preventative maintenances\nAuthor instrument operational SOPs as needed\nCoordinate/interface/host vendors on site\nChampions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive\nActions (CA/Client)\nActs as the liaison between Digital Plant (IT) and lab departments\nEducation, Qualifications and Experience Required:\nBachelor’s degree in relevant scientific, engineering, or computer-based area with 5 – 7 years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.\nQuality management system experience including document control/management, change controls,\ninvestigations, deviations, electronic validation databases, asset management database\nKnowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery\nIncumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects\nDemonstrated success in cross functional influencing, strong communication, and collaboration skills\nWorking knowledge of laboratory systems such as Empower, NuGenesis and other software programs, including\nMicrosoft Office Applications, preferred.\nMust have equipment validation experience\nMust have GMP experience\nMust have Quality Management System (QMS) experience\nExperience in Computer System Validation is a plus.\nExperience in any asset management software is a plus.\nJob Type: Contract\nPay: $60.00 - $65.00 per hour\nSchedule:\n8 hour shift\nMonday to Friday\nAbility to commute/relocate:\nDevens, MA 01434: Reliably commute or planning to relocate before starting work (Required)\nExperience:\nPharmaceutical: 5 years (Required)\nLaboratory Qualification: 5 years (Required)\nChange Controls/Deviations and CAPAs.: 5 years (Required)\nWork Location: In person","datePosted":"2026-08-06T11:27:39.742Z","dateModified":"2026-08-06T11:27:39.742Z","hiringOrganization":{"@type":"Organization","name":"Eclaro","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Devens","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b69936f5beab73f3ab429022"},"url":"https://jobsearcher.com/jobs/b69936f5beab73f3ab429022"}}