{"schemaVersion":"jobsearcher.job.v1","id":"4d63dd5e2fbdeff47dd9474c","url":"https://jobsearcher.com/jobs/4d63dd5e2fbdeff47dd9474c","canonicalUrl":"https://jobsearcher.com/jobs/4d63dd5e2fbdeff47dd9474c","title":"Computer Validation Engineer IV","description":"Overview:\n\nThe incumbent will oversee and coordinate new projects related to validation deliverables and qualifications to ensure existing and new system installations meet all internal and external compliance requirements such as 21 CFR Part 11, EU GMP, and GLP requirements throughout the systems development life cycle. This position works on moderately complex problems of diverse scope where analysis of data requires solid evaluation of identifiable factors.\n\nResponsibilities:\nWork closely with GMP, GLP and IT business units to provide Computer System Validation Services to implement validated system and maintain the validated state of current systems\nActs as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management for GMP/GLP systems.\nApplies and enhances existing computer system validation programs for the validation of new production and manufacturing /laboratory computer systems, including major capital projects and computer systems for both early phase and commercial phase.\nEnsure existing systems and new systems are compliant with all applicable regulations based on their applicable use at Celldex\nCoordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems\nDevelop Standard Operating Procedures and policies to support computer validation systems for GMP/GLP\nDevelop training materials and provide training to Celldex staff related to the computer validation systems for GMP/GLP\nCollaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and IT\nManages multiple simultaneous validation, revalidation, and change control activities\nDevelop validation project management deliverables as needed such as plans, qualification protocols, gap assessments, risk/impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change control / change management and continuous improvement for GMP/GLP\nEvaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes for GMP/GLP systems\nSupport and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state for GMP/GLP systems\nQualifications:\n8+ years applicable work experience in cGMP/GLP related industry\nBachelor's degree in a technical discipline (computer or biological sciences), or equivalent\nDemonstrated experience coordinating validation projects in validated and regulated environments\nDemonstrated experience reviewing / evaluating legacy systems, and provide gap reports/assessments per each system per 21 CFR Par 11 compliance\nExperience with network qualification required\nExperience with ERP system qualification required\nExperience with Veeva products required\nSuccessful implementation of ERP, Veeva, lab, production systems required.\nProven track record in validation and qualification of complex computer systems\nDemonstrable knowledge of GxP environs such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, 15 and GAMP standards\nExperience with qualification of AI preferred\nExperience with qualification of lab software systems required\nExcellent writing and communications skills\nExcellent people and interpersonal skills\nHigh level of collaboration and working on and leading teams\nCompensation Statement: The expected base salary for this position is: $101005.00 to $131175.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.","company":"Celldex Therapeutics","rawCompany":"celldex therapeutics","city":"Fall River","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-08-31T10:59:35.473Z","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":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541512","title":"Computer Systems Design Services","slug":"computer-systems-design-services"},{"code":"334111","title":"Electronic Computer Manufacturing","slug":"electronic-computer-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Computer Validation Engineer IV","description":"Overview:\n\nThe incumbent will oversee and coordinate new projects related to validation deliverables and qualifications to ensure existing and new system installations meet all internal and external compliance requirements such as 21 CFR Part 11, EU GMP, and GLP requirements throughout the systems development life cycle. This position works on moderately complex problems of diverse scope where analysis of data requires solid evaluation of identifiable factors.\n\nResponsibilities:\nWork closely with GMP, GLP and IT business units to provide Computer System Validation Services to implement validated system and maintain the validated state of current systems\nActs as a quality contact and primary Subject Matter Expert (SME) for Computer System Validation (CSV) and Quality Risk Management for GMP/GLP systems.\nApplies and enhances existing computer system validation programs for the validation of new production and manufacturing /laboratory computer systems, including major capital projects and computer systems for both early phase and commercial phase.\nEnsure existing systems and new systems are compliant with all applicable regulations based on their applicable use at Celldex\nCoordinate Incident Management, along with the related corrective and preventative actions required to establish/maintain validated systems\nDevelop Standard Operating Procedures and policies to support computer validation systems for GMP/GLP\nDevelop training materials and provide training to Celldex staff related to the computer validation systems for GMP/GLP\nCollaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and IT\nManages multiple simultaneous validation, revalidation, and change control activities\nDevelop validation project management deliverables as needed such as plans, qualification protocols, gap assessments, risk/impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change control / change management and continuous improvement for GMP/GLP\nEvaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes for GMP/GLP systems\nSupport and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state for GMP/GLP systems\nQualifications:\n8+ years applicable work experience in cGMP/GLP related industry\nBachelor's degree in a technical discipline (computer or biological sciences), or equivalent\nDemonstrated experience coordinating validation projects in validated and regulated environments\nDemonstrated experience reviewing / evaluating legacy systems, and provide gap reports/assessments per each system per 21 CFR Par 11 compliance\nExperience with network qualification required\nExperience with ERP system qualification required\nExperience with Veeva products required\nSuccessful implementation of ERP, Veeva, lab, production systems required.\nProven track record in validation and qualification of complex computer systems\nDemonstrable knowledge of GxP environs such as cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, 15 and GAMP standards\nExperience with qualification of AI preferred\nExperience with qualification of lab software systems required\nExcellent writing and communications skills\nExcellent people and interpersonal skills\nHigh level of collaboration and working on and leading teams\nCompensation Statement: The expected base salary for this position is: $101005.00 to $131175.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.","datePosted":"2026-08-31T10:59:35.473Z","dateModified":"2026-08-31T10:59:35.473Z","hiringOrganization":{"@type":"Organization","name":"Celldex Therapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Fall River","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"4d63dd5e2fbdeff47dd9474c"},"url":"https://jobsearcher.com/jobs/4d63dd5e2fbdeff47dd9474c"}}