{"schemaVersion":"jobsearcher.job.v1","id":"98f7ffabe7d28b5c09b7e5ee","url":"https://jobsearcher.com/jobs/98f7ffabe7d28b5c09b7e5ee","canonicalUrl":"https://jobsearcher.com/jobs/98f7ffabe7d28b5c09b7e5ee","title":"Validation Program Manager and Site Lead","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\n\nWe are seeking a Validation Program Manager and Site Lead to manage an annual Quality Control and Quality Assurance Validation Maintenance Program in Juncos Puerto Rico. The position will provide leadership, supervision, resource coordination, planning, compliance oversight, and client governance for validation services supporting QC Laboratory and QA Incoming operations.\n\nValidation Program Manager and Site Lead\n\nKey Responsibilities\n\nProvide day-to-day leadership and management oversight for the assigned validation team.\nDevelop and maintain the integrated validation master schedule and resource-loading plan.\nCoordinate execution of:\nPeriodic monitoring of three laboratory autoclaves and four laboratory isolators.\nPeriodic reviews of 38 controlled-temperature chambers, 14 ISO 5 laminar-flow hoods, nine inspection booths, and two glass washers.\nPeriodic reviews of 42 computerized systems.\nApproximately six regulatory audits or inspections annually.\nApproximately four to six regulatory submissions annually.\nMaintain validation master plans, schedules, deliverable trackers, and resource forecasts.\nEnsure timely onboarding, training, system access, gowning qualifications, and site-access readiness for all assigned personnel.\nEstablish and monitor service-level agreements, deliverables, priorities, and escalation pathways.\nParticipate in Work Center Team, production scheduling, NPI, project, governance, and client-status meetings.\nDevelop and communicate monthly progress reports, KPI dashboards, schedule adherence, success rates, failed or invalid runs, training compliance, quality events, and team efficiencies.\nProvide oversight of validation documentation generated and routed through Kneat, CDOCs, or other systems.\nCoordinate audit-readiness activities, anticipated inspection requests, inspection requests, pressure-test preparation, and four-block presentations.\nSupport preparation and review of CMC validation content associated with equipment qualification, periodic monitoring, sterilization, and cleaning validation.\nEnsure deviations, discrepancies, CAPAs, and quality or safety events associated with supplier execution are addressed within established timelines.\nManage time-and-material reconciliation, earned-value reporting, and labor-model information.\nEnsure personnel availability for evening, night, weekend, or holiday execution when required.\n\nQualifications\n\nBachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.\nEight or more years of pharmaceutical or biotechnology validation experience.\nAt least three years leading validation programs or multidisciplinary technical teams.\nDemonstrated experience with equipment qualification, periodic review, periodic monitoring, validation lifecycle documentation, and inspection readiness.\nExperience supporting FDA or other regulatory inspections in a cGMP environment.\nStrong working knowledge of Kneat, CDOCs, Smartsheet, MS Project, TrackWise, or equivalent systems.\nExcellent technical writing, client communication, scheduling, and team-management capabilities.\nAbility to communicate professionally in English and Spanish.\n\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","company":"Validation","rawCompany":"validation","city":"Manati","state":"PR","isRemote":false,"isActive":false,"createdAt":"2026-09-18T11:24:24.120Z","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":"11-9121.00","title":"Natural Sciences Managers","slug":"natural-sciences-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"},{"code":"541330","title":"Engineering Services","slug":"engineering-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Validation Program Manager and Site Lead","description":"Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.\n\nWe are seeking a Validation Program Manager and Site Lead to manage an annual Quality Control and Quality Assurance Validation Maintenance Program in Juncos Puerto Rico. The position will provide leadership, supervision, resource coordination, planning, compliance oversight, and client governance for validation services supporting QC Laboratory and QA Incoming operations.\n\nValidation Program Manager and Site Lead\n\nKey Responsibilities\n\nProvide day-to-day leadership and management oversight for the assigned validation team.\nDevelop and maintain the integrated validation master schedule and resource-loading plan.\nCoordinate execution of:\nPeriodic monitoring of three laboratory autoclaves and four laboratory isolators.\nPeriodic reviews of 38 controlled-temperature chambers, 14 ISO 5 laminar-flow hoods, nine inspection booths, and two glass washers.\nPeriodic reviews of 42 computerized systems.\nApproximately six regulatory audits or inspections annually.\nApproximately four to six regulatory submissions annually.\nMaintain validation master plans, schedules, deliverable trackers, and resource forecasts.\nEnsure timely onboarding, training, system access, gowning qualifications, and site-access readiness for all assigned personnel.\nEstablish and monitor service-level agreements, deliverables, priorities, and escalation pathways.\nParticipate in Work Center Team, production scheduling, NPI, project, governance, and client-status meetings.\nDevelop and communicate monthly progress reports, KPI dashboards, schedule adherence, success rates, failed or invalid runs, training compliance, quality events, and team efficiencies.\nProvide oversight of validation documentation generated and routed through Kneat, CDOCs, or other systems.\nCoordinate audit-readiness activities, anticipated inspection requests, inspection requests, pressure-test preparation, and four-block presentations.\nSupport preparation and review of CMC validation content associated with equipment qualification, periodic monitoring, sterilization, and cleaning validation.\nEnsure deviations, discrepancies, CAPAs, and quality or safety events associated with supplier execution are addressed within established timelines.\nManage time-and-material reconciliation, earned-value reporting, and labor-model information.\nEnsure personnel availability for evening, night, weekend, or holiday execution when required.\n\nQualifications\n\nBachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.\nEight or more years of pharmaceutical or biotechnology validation experience.\nAt least three years leading validation programs or multidisciplinary technical teams.\nDemonstrated experience with equipment qualification, periodic review, periodic monitoring, validation lifecycle documentation, and inspection readiness.\nExperience supporting FDA or other regulatory inspections in a cGMP environment.\nStrong working knowledge of Kneat, CDOCs, Smartsheet, MS Project, TrackWise, or equivalent systems.\nExcellent technical writing, client communication, scheduling, and team-management capabilities.\nAbility to communicate professionally in English and Spanish.\n\nAt Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.\n\nExcited to build something meaningful together? We look forward to hearing from you.\n\nValidation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.","datePosted":"2026-09-18T11:24:24.120Z","dateModified":"2026-09-18T11:24:24.120Z","hiringOrganization":{"@type":"Organization","name":"Validation","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Manati","addressRegion":"PR","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"98f7ffabe7d28b5c09b7e5ee"},"url":"https://jobsearcher.com/jobs/98f7ffabe7d28b5c09b7e5ee"}}