{"schemaVersion":"jobsearcher.job.v1","id":"b0ffcb10da03b7cbe8a8b3ad","url":"https://jobsearcher.com/jobs/b0ffcb10da03b7cbe8a8b3ad","canonicalUrl":"https://jobsearcher.com/jobs/b0ffcb10da03b7cbe8a8b3ad","title":"Validation Engineer","description":"Validation Engineer\nResponsibilities\nThe Validation Engineer will provide validation, technical, and compliance oversight for Cell Therapy and Viral Vector manufacturing and laboratory equipment throughout the full equipment lifecycle. This role will work with the Manufacturing, Quality Control, Analytical Development, Process Development, Quality Assurance, and IT departments to ensure equipment, systems, and processes are compliant with GMP and regulatory requirements. Responsibilities will include development of and execution of equipment qualifications, validation documentation, change control support, deviation investigations, and technical risk assessments to maintain equipment validated states. This role supports day-to-day operations, equipment qualification, preventive maintenance, and troubleshooting across all critical GMP departments, including such equipment as incubators, Biological Safety Cabinets, Lovos, Prodigies, and any new Cell Therapy equipment.\n\nEstablish and maintain preventive and predictive maintenance programs while ensuring equipment remains in a validated and qualified state.\n\nTroubleshoot equipment issues, perform root cause analysis, and implement corrective and preventive actions (CAPA) in alignment with validation and quality requirements.\n\nCollaborate with external service providers to ensure maintenance and calibration activities comply with GMP and do not compromise equipment qualification status.\n\nUpdate Maximo CMMS with accurate documentation of maintenance and qualification activities in accordance with data integrity principles.\n\nAuthor and execute IQ/OQ/PQ protocols and reports in compliance with GMP, FDA, and ICH guidelines.\n\nPartner with Quality, Validation, and Manufacturing teams to ensure equipment qualification documentation is accurate and audit ready.\n\nManage equipment change controls including impact assessments on validated state and support for deviations and CAPAs.\n\nTrain manufacturing and laboratory staff on proper equipment operation procedures, ensuring adherence to validated methods and GMP requirements.\n\nEnsure that changes, maintenance and other interventions are assessed for impact and do not compromise the validated/qualified state of equipment.\n\nLead/support tech transfer of new equipment and unit operations with a focus on qualification, validation strategy, and lifecycle management.\n\nProvide technical oversight during development of equipment and Equipment system User Requirements Specifications (URS), Design Qualification (DQ), and related validation documentation.\n\nProvide guidance in development of test plans for Verification packages including risk-based validation approaches and critical component assessment.\n\nProvide guidance on key elements of return to service requirements including requalification and validation impact assessment after maintenance or interventions.\n\nAssist during internal and external audits, serving as validation SME and providing compliant documentation and technical justification.\n\nAssist and support routine maintenance activities, ensuring alignment with validated state requirements.\n\nWork cross functionally among Equipment Development, Manufacturing, Quality Control, Quality Assurance, IT to support full equipment lifecycle management from design through qualification and operation.\n\nMeet and report key performance indicators in alignment with Cell Therapy Manufacturing goals.\n\nIdentify opportunities to optimize equipment performance, reduce costs, and enhance reliability through innovative solutions and best practices.\n\nPerform other duties as assigned.\n\nQualifications/Skills\n\nBachelor’s degree in Engineering.\n\n7+ yr’s. relevant experience, preferably in the biotech industry or equivalent combination of education and experience.\n\nProficient with Microsoft Office: Word, Excel, Outlook and Teams.\n\nExperience in Equipment Development laboratory operations with various cell manufacturing platforms including closed systems for the development of T-cell therapy products.\n\nDemonstrated ability to collaborate effectively in a multi-disciplinary team.\n\nDemonstrated strong communication skills, interpersonal skills and a superior drive for results.\n\nExcellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.\n\nExcellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.\n\nPrevious experience with audits preferred.\n\nMeticulous attention to detail in terms of documentation and following SOPs.\n\nAble to work a flexible schedule including nights, weekends, and holidays with short advance notice.\n\n#J-18808-Ljbffr","company":"Planet Pharma Group","rawCompany":"planet pharma group","city":"Houston","state":"TX","isRemote":false,"isActive":true,"createdAt":"2026-06-17T03:38:10.228Z","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":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Engineer","description":"Validation Engineer\nResponsibilities\nThe Validation Engineer will provide validation, technical, and compliance oversight for Cell Therapy and Viral Vector manufacturing and laboratory equipment throughout the full equipment lifecycle. This role will work with the Manufacturing, Quality Control, Analytical Development, Process Development, Quality Assurance, and IT departments to ensure equipment, systems, and processes are compliant with GMP and regulatory requirements. Responsibilities will include development of and execution of equipment qualifications, validation documentation, change control support, deviation investigations, and technical risk assessments to maintain equipment validated states. This role supports day-to-day operations, equipment qualification, preventive maintenance, and troubleshooting across all critical GMP departments, including such equipment as incubators, Biological Safety Cabinets, Lovos, Prodigies, and any new Cell Therapy equipment.\n\nEstablish and maintain preventive and predictive maintenance programs while ensuring equipment remains in a validated and qualified state.\n\nTroubleshoot equipment issues, perform root cause analysis, and implement corrective and preventive actions (CAPA) in alignment with validation and quality requirements.\n\nCollaborate with external service providers to ensure maintenance and calibration activities comply with GMP and do not compromise equipment qualification status.\n\nUpdate Maximo CMMS with accurate documentation of maintenance and qualification activities in accordance with data integrity principles.\n\nAuthor and execute IQ/OQ/PQ protocols and reports in compliance with GMP, FDA, and ICH guidelines.\n\nPartner with Quality, Validation, and Manufacturing teams to ensure equipment qualification documentation is accurate and audit ready.\n\nManage equipment change controls including impact assessments on validated state and support for deviations and CAPAs.\n\nTrain manufacturing and laboratory staff on proper equipment operation procedures, ensuring adherence to validated methods and GMP requirements.\n\nEnsure that changes, maintenance and other interventions are assessed for impact and do not compromise the validated/qualified state of equipment.\n\nLead/support tech transfer of new equipment and unit operations with a focus on qualification, validation strategy, and lifecycle management.\n\nProvide technical oversight during development of equipment and Equipment system User Requirements Specifications (URS), Design Qualification (DQ), and related validation documentation.\n\nProvide guidance in development of test plans for Verification packages including risk-based validation approaches and critical component assessment.\n\nProvide guidance on key elements of return to service requirements including requalification and validation impact assessment after maintenance or interventions.\n\nAssist during internal and external audits, serving as validation SME and providing compliant documentation and technical justification.\n\nAssist and support routine maintenance activities, ensuring alignment with validated state requirements.\n\nWork cross functionally among Equipment Development, Manufacturing, Quality Control, Quality Assurance, IT to support full equipment lifecycle management from design through qualification and operation.\n\nMeet and report key performance indicators in alignment with Cell Therapy Manufacturing goals.\n\nIdentify opportunities to optimize equipment performance, reduce costs, and enhance reliability through innovative solutions and best practices.\n\nPerform other duties as assigned.\n\nQualifications/Skills\n\nBachelor’s degree in Engineering.\n\n7+ yr’s. relevant experience, preferably in the biotech industry or equivalent combination of education and experience.\n\nProficient with Microsoft Office: Word, Excel, Outlook and Teams.\n\nExperience in Equipment Development laboratory operations with various cell manufacturing platforms including closed systems for the development of T-cell therapy products.\n\nDemonstrated ability to collaborate effectively in a multi-disciplinary team.\n\nDemonstrated strong communication skills, interpersonal skills and a superior drive for results.\n\nExcellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.\n\nExcellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.\n\nPrevious experience with audits preferred.\n\nMeticulous attention to detail in terms of documentation and following SOPs.\n\nAble to work a flexible schedule including nights, weekends, and holidays with short advance notice.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:38:10.228Z","dateModified":"2026-06-17T03:38:10.228Z","hiringOrganization":{"@type":"Organization","name":"Planet Pharma Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Houston","addressRegion":"TX","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b0ffcb10da03b7cbe8a8b3ad"},"url":"https://jobsearcher.com/jobs/b0ffcb10da03b7cbe8a8b3ad"}}