{"schemaVersion":"jobsearcher.job.v1","id":"f20e4108fdd629ed67452e46","url":"https://jobsearcher.com/jobs/f20e4108fdd629ed67452e46","canonicalUrl":"https://jobsearcher.com/jobs/f20e4108fdd629ed67452e46","title":"Quality Engineer II","description":"At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best‑in‑class bioanalytical services. We are tirelessly committed to our customers by being solution‑oriented and deadline‑driven. . . and we are growing. Our culture is fast‑paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life‑changing, life‑saving therapeutics to the patients who need them.\n\nThe Quality Engineer II is responsible for providing quality assurance (QA) oversight of computer validations and equipment qualifications. He or she is responsible for maintaining a strong collaborative partnership with cross‑functional team members that facilitates organizational success and meets business needs.\n\nEssential Responsibilities\n\nProvides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security)\n\nEnsures all activities related to applicable computer systems and equipment qualifications are in compliance with national/international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs\n\nPerforms the quality review of SOPs, policies, and the computer validation and equipment qualification master plan, as required\n\nResponsible for QA oversight of the computer system validation and equipment management programs as well as working with other departments/consultants/vendors to plan, implement, and complete all validation/qualification projects (e.g. LIMS, ELN, QCBD, equipment software, etc.)\n\nResponsible for system administration of Quality Management Systems (e.g. ZenQMS, Blue Mountain)\n\nResponsible for electronic Archives oversight\n\nResponsible for the maintenance of the Computer System Validation Status listing and Equipment Master Listing\n\nReviews and approves equipment out of tolerances investigations\n\nPerforms vendor qualification of vendors, contractors, consultants, and technicians that will participate in computer validation/equipment qualification activities\n\nConfirms periodic reviews of validated computer systems and equipment are performed, including reviewing periodic reviews and confirm all required follow‑up actions are completed\n\nResponsible for QA review and approval of validation documentation for new and existing computer systems/equipment subject to validation\n\nReviews and approves for QA, deviations incident reports for executed validation and qualification documents. Ensures assignable causes are identified and addresses corrective actions, as needed\n\nServes as QA representative for the testing of the Business Continuity (e.g. IT testing) and computer system validations and equipment qualification during regulatory agency and sponsor inspections\n\nResponsible for QA review and approval of change controls and Out of Tolerances to ensure timely closure\n\nPerform duties with minimal QA Engineer Management oversite\n\nAdditional Responsibilities\n\nOther duties as needed\n\nMinimum Preferred Qualifications - Education/Experience\n\nBachelor’s degree in engineering, information technology, computer science, or related discipline\n\nNot less than five (5) years’ experience in pharmaceutical/GxP/regulated environment\n\nDirect hands‑on experience with computer systems validation and/or equipment qualifications\n\nDirect hands‑on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)\n\nMinimum Preferred Qualifications - Skills\n\nProject management skills not required but preferred.\n\nKnowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles\n\nAbility to provide QA oversight for the implementation, maintenance, and enhancement of a LIMS system, ensuring the system remains in a validated state throughout its lifecycle.\n\nAbility to apply validation engineering principles to the design and implementation of projects\n\nKnowledge of IT infrastructure and information database systems\n\nAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies\n\nAbility to work in fast‑paced environment where multiple projects are in process and must be completed in a timely manner\n\nAdvanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)\n\nExcellent written and verbal communication skills\n\nVersatility, flexibility, and willingness to work within constantly changing priorities\n\nAbility to deal effectively with a diversity of individuals at all organizational levels\n\nSupervisory Responsibility\n\nThis position has no supervisory responsibility\n\nSupervision Received\n\nInfrequent supervision and instructions\n\nFrequently exercises discretionary authority\n\nWorking Environment\n\nPrimarily office\n\nRoutinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets\n\nPosition Type and Expected Hours of Work\n\nThis is a full‑time position\n\nSome flexibility in hours is allowed, by the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook\n\nOccasional weekend, holiday, and evening work required\n\nBENEFITS AND OTHER PERKS\n\nMedical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program\n\nCOMMITMENT TO EQUAL OPPORTUNITY\nBioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.\n\nTo learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use .\n\n#J-18808-Ljbffr","company":"Socket","rawCompany":"socket","city":"Durham","state":"NC","isRemote":false,"isActive":true,"createdAt":"2026-09-16T03:25:57.451Z","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":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer II","description":"At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best‑in‑class bioanalytical services. We are tirelessly committed to our customers by being solution‑oriented and deadline‑driven. . . and we are growing. Our culture is fast‑paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life‑changing, life‑saving therapeutics to the patients who need them.\n\nThe Quality Engineer II is responsible for providing quality assurance (QA) oversight of computer validations and equipment qualifications. He or she is responsible for maintaining a strong collaborative partnership with cross‑functional team members that facilitates organizational success and meets business needs.\n\nEssential Responsibilities\n\nProvides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security)\n\nEnsures all activities related to applicable computer systems and equipment qualifications are in compliance with national/international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs\n\nPerforms the quality review of SOPs, policies, and the computer validation and equipment qualification master plan, as required\n\nResponsible for QA oversight of the computer system validation and equipment management programs as well as working with other departments/consultants/vendors to plan, implement, and complete all validation/qualification projects (e.g. LIMS, ELN, QCBD, equipment software, etc.)\n\nResponsible for system administration of Quality Management Systems (e.g. ZenQMS, Blue Mountain)\n\nResponsible for electronic Archives oversight\n\nResponsible for the maintenance of the Computer System Validation Status listing and Equipment Master Listing\n\nReviews and approves equipment out of tolerances investigations\n\nPerforms vendor qualification of vendors, contractors, consultants, and technicians that will participate in computer validation/equipment qualification activities\n\nConfirms periodic reviews of validated computer systems and equipment are performed, including reviewing periodic reviews and confirm all required follow‑up actions are completed\n\nResponsible for QA review and approval of validation documentation for new and existing computer systems/equipment subject to validation\n\nReviews and approves for QA, deviations incident reports for executed validation and qualification documents. Ensures assignable causes are identified and addresses corrective actions, as needed\n\nServes as QA representative for the testing of the Business Continuity (e.g. IT testing) and computer system validations and equipment qualification during regulatory agency and sponsor inspections\n\nResponsible for QA review and approval of change controls and Out of Tolerances to ensure timely closure\n\nPerform duties with minimal QA Engineer Management oversite\n\nAdditional Responsibilities\n\nOther duties as needed\n\nMinimum Preferred Qualifications - Education/Experience\n\nBachelor’s degree in engineering, information technology, computer science, or related discipline\n\nNot less than five (5) years’ experience in pharmaceutical/GxP/regulated environment\n\nDirect hands‑on experience with computer systems validation and/or equipment qualifications\n\nDirect hands‑on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)\n\nMinimum Preferred Qualifications - Skills\n\nProject management skills not required but preferred.\n\nKnowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles\n\nAbility to provide QA oversight for the implementation, maintenance, and enhancement of a LIMS system, ensuring the system remains in a validated state throughout its lifecycle.\n\nAbility to apply validation engineering principles to the design and implementation of projects\n\nKnowledge of IT infrastructure and information database systems\n\nAbility to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies\n\nAbility to work in fast‑paced environment where multiple projects are in process and must be completed in a timely manner\n\nAdvanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)\n\nExcellent written and verbal communication skills\n\nVersatility, flexibility, and willingness to work within constantly changing priorities\n\nAbility to deal effectively with a diversity of individuals at all organizational levels\n\nSupervisory Responsibility\n\nThis position has no supervisory responsibility\n\nSupervision Received\n\nInfrequent supervision and instructions\n\nFrequently exercises discretionary authority\n\nWorking Environment\n\nPrimarily office\n\nRoutinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets\n\nPosition Type and Expected Hours of Work\n\nThis is a full‑time position\n\nSome flexibility in hours is allowed, by the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook\n\nOccasional weekend, holiday, and evening work required\n\nBENEFITS AND OTHER PERKS\n\nMedical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays (9 scheduled; 5 floating), 401k with Employer Match, Employee Referral Program\n\nCOMMITMENT TO EQUAL OPPORTUNITY\nBioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.\n\nTo learn more about how we collect, use, and protect your information, please review our Privacy Policy and Terms of Use .\n\n#J-18808-Ljbffr","datePosted":"2026-09-16T03:25:57.451Z","dateModified":"2026-09-16T03:25:57.451Z","hiringOrganization":{"@type":"Organization","name":"Socket","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Durham","addressRegion":"NC","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f20e4108fdd629ed67452e46"},"url":"https://jobsearcher.com/jobs/f20e4108fdd629ed67452e46"}}