{"schemaVersion":"jobsearcher.job.v1","id":"d1ea4623246aa5065bf18ee3","url":"https://jobsearcher.com/jobs/d1ea4623246aa5065bf18ee3","canonicalUrl":"https://jobsearcher.com/jobs/d1ea4623246aa5065bf18ee3","title":"QA Engineer","description":"applying with LinkedIn\n\na.dialogApplyBtn { display: none; }\nQA Engineer\nDate: Aug 17, 2026\nLocation:\n\nFL, US\n\n#job-location.job-location-inline { display: inline; }\nCompany: Lupin\nHeader\nJob Description\n\nThe QA Engineer is responsible for providing Quality Assurance oversight of Engineering and Facilities activities, with a primary focus on reviewing and approving qualification and validation documentation, including IQ/OQ/PQ protocols and reports, commissioning records, Computer System Validation (CSV) packages, and related GMP documentation.\n\nThis role ensures engineering systems, utilities, equipment qualification activities, and facility operations are conducted in compliance with cGMP, FDA, EMA, and ICH requirements, with a strong emphasis on data integrity (ALCOA+), documentation practices, and risk-based decision making. The position also supports vendor quality management, internal audits, and continuous improvement initiatives. This role reports to the QA Manager, Analytical.\n\nEssential Duties and Responsibilities\n\nEngineering & Facilities Quality Assurance\n\nReview and approve engineering documentation, SOPs, protocols, records, and GMP documentation related to Engineering, EHS, and Facilities activities.\nReview and approve equipment qualification, calibration, validation, and CSV documentation.\nReview facility and utility documentation, including HVAC and water systems, ensuring systems remain qualified and maintained in a validated state.\nReview maintenance, pest control, and facility records for compliance with site procedures and regulatory requirements.\nReview environmental monitoring data, initiate Quality Events (QEs) as needed, and perform trend analysis.\nReview deviations, investigations, incidents, and CAPAs related to facilities, equipment, and engineering activities.\nMonitor quality metrics and documentation to support internal reporting and Annual Product Reviews (APRs).\n\nVendor Quality Management\n\nSupport vendor qualification, requalification, audits, and risk assessments.\nReview vendor change notifications and assess potential quality impact.\nCollaborate with cross-functional teams to resolve supplier quality issues.\nMonitor vendor performance metrics and KPIs.\n\nInternal Audit & Compliance Support\n\nSupport quality systems including deviations, CAPAs, change control, document control, and inspection readiness.\nParticipate in internal audits and support regulatory inspections and customer audits.\nAssist with corrective and preventive action implementation.\nDrive continuous improvement initiatives to strengthen quality systems and compliance.\nQualification and Experience\n\nBachelor’s degree (B.S.) in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or a related scientific discipline.\nMinimum of five (5) years of Quality Assurance experience in an FDA-regulated pharmaceutical and/or medical device manufacturing environment.\nAt least three (3) years of direct QA experience supporting Engineering and Facilities functions, including:\nReview and approval of IQ/OQ/PQ protocols and reports.\nEquipment qualification and validation lifecycle activities.\nEngineering documentation and GMP record review.\nStrong knowledge of cGMP regulations, ICH guidelines, FDA, EMA, and other applicable global regulatory requirements.\nWorking knowledge of SOPs, qualification and validation principles, HVAC systems, water systems, ALCOA+ data integrity principles, and associated regulatory expectations.\nProficiency in Microsoft Office applications and electronic Quality Management Systems (eQMS).\nStrong organizational, analytical, and problem-solving skills.\nExcellent verbal and written communication skills in English.\n\nLupin is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected characteristic in accordance with applicable federal, state, and local laws.\n\nCompetencies\nCollaboration\nCustomer Centricity\nDeveloping Talent\nInnovation & Creativity\nProcess Excellence\nResult Orientation\nStakeholder Management\nStrategic Agility\n\n»\n\napplying with LinkedIn\n\na.dialogApplyBtn { display: none; }","company":"Lupin","rawCompany":"lupin","city":"Hernando","state":"FL","isRemote":false,"isActive":false,"createdAt":"2026-08-19T20:06:40.673Z","occupations":[{"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"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"QA Engineer","description":"applying with LinkedIn\n\na.dialogApplyBtn { display: none; }\nQA Engineer\nDate: Aug 17, 2026\nLocation:\n\nFL, US\n\n#job-location.job-location-inline { display: inline; }\nCompany: Lupin\nHeader\nJob Description\n\nThe QA Engineer is responsible for providing Quality Assurance oversight of Engineering and Facilities activities, with a primary focus on reviewing and approving qualification and validation documentation, including IQ/OQ/PQ protocols and reports, commissioning records, Computer System Validation (CSV) packages, and related GMP documentation.\n\nThis role ensures engineering systems, utilities, equipment qualification activities, and facility operations are conducted in compliance with cGMP, FDA, EMA, and ICH requirements, with a strong emphasis on data integrity (ALCOA+), documentation practices, and risk-based decision making. The position also supports vendor quality management, internal audits, and continuous improvement initiatives. This role reports to the QA Manager, Analytical.\n\nEssential Duties and Responsibilities\n\nEngineering & Facilities Quality Assurance\n\nReview and approve engineering documentation, SOPs, protocols, records, and GMP documentation related to Engineering, EHS, and Facilities activities.\nReview and approve equipment qualification, calibration, validation, and CSV documentation.\nReview facility and utility documentation, including HVAC and water systems, ensuring systems remain qualified and maintained in a validated state.\nReview maintenance, pest control, and facility records for compliance with site procedures and regulatory requirements.\nReview environmental monitoring data, initiate Quality Events (QEs) as needed, and perform trend analysis.\nReview deviations, investigations, incidents, and CAPAs related to facilities, equipment, and engineering activities.\nMonitor quality metrics and documentation to support internal reporting and Annual Product Reviews (APRs).\n\nVendor Quality Management\n\nSupport vendor qualification, requalification, audits, and risk assessments.\nReview vendor change notifications and assess potential quality impact.\nCollaborate with cross-functional teams to resolve supplier quality issues.\nMonitor vendor performance metrics and KPIs.\n\nInternal Audit & Compliance Support\n\nSupport quality systems including deviations, CAPAs, change control, document control, and inspection readiness.\nParticipate in internal audits and support regulatory inspections and customer audits.\nAssist with corrective and preventive action implementation.\nDrive continuous improvement initiatives to strengthen quality systems and compliance.\nQualification and Experience\n\nBachelor’s degree (B.S.) in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or a related scientific discipline.\nMinimum of five (5) years of Quality Assurance experience in an FDA-regulated pharmaceutical and/or medical device manufacturing environment.\nAt least three (3) years of direct QA experience supporting Engineering and Facilities functions, including:\nReview and approval of IQ/OQ/PQ protocols and reports.\nEquipment qualification and validation lifecycle activities.\nEngineering documentation and GMP record review.\nStrong knowledge of cGMP regulations, ICH guidelines, FDA, EMA, and other applicable global regulatory requirements.\nWorking knowledge of SOPs, qualification and validation principles, HVAC systems, water systems, ALCOA+ data integrity principles, and associated regulatory expectations.\nProficiency in Microsoft Office applications and electronic Quality Management Systems (eQMS).\nStrong organizational, analytical, and problem-solving skills.\nExcellent verbal and written communication skills in English.\n\nLupin is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other protected characteristic in accordance with applicable federal, state, and local laws.\n\nCompetencies\nCollaboration\nCustomer Centricity\nDeveloping Talent\nInnovation & Creativity\nProcess Excellence\nResult Orientation\nStakeholder Management\nStrategic Agility\n\n»\n\napplying with LinkedIn\n\na.dialogApplyBtn { display: none; }","datePosted":"2026-08-19T20:06:40.673Z","dateModified":"2026-08-19T20:06:40.673Z","hiringOrganization":{"@type":"Organization","name":"Lupin","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Hernando","addressRegion":"FL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"d1ea4623246aa5065bf18ee3"},"url":"https://jobsearcher.com/jobs/d1ea4623246aa5065bf18ee3"}}