{"schemaVersion":"jobsearcher.job.v1","id":"e27fa3061c0da42e279f85cc","url":"https://jobsearcher.com/jobs/e27fa3061c0da42e279f85cc","canonicalUrl":"https://jobsearcher.com/jobs/e27fa3061c0da42e279f85cc","title":"Quality Engineer","description":"Position Type:\nFull-Time\n\nLocation:\nAlachua, FL (Onsite Monday - Friday)\n\nReporting to:\nDirector of Quality\n\nPosition Overview:\nThe Quality Engineer will partner and collaborate with the QA and Engineering teams to ensure that all required qualifications and validations are performed for facilities, systems, software, and equipment, meeting all partner needs in compliance with standard operating procedures. Specific activities include review of study design, protocols, execution and reports associated with equipment and process validation studies; provide review and approval of laboratory method validation and verification; provide technical reviews for Quality risk assessments, investigations and process evaluations for compounding and laboratory equipment as applicable.\n\nKey Responsibilities:\n\nEnsure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality procedures.\n\nDevelop, review, and approve validation documentation including validation plans, protocols (IQ, OQ, PQ), reports and summary documents.\n\nSupport lifecycle management of validated systems and software, including requalification, change control, and periodic review.\n\nProvide guidance on risk-based validation strategies aligned with industry standards (e.g., GAMP, ICH Q9).\n\nProvide quality engineering support to analytical laboratories.\n\nAssist with equipment validation/verification and troubleshooting activities; support laboratory equipment qualification and lifecycle management.\n\nLead or participate in cross-functional quality improvement projects and drive initiatives related to process optimization, validation efficiency, and quality system improvements.\n\nSupport implementation of new technologies, automation, or process changes requiring validation oversight.\n\nProvide technical expertise during new product introduction (NPI) or process transfer activities.\n\nProvide day-to-day quality engineering support to operations.\n\nSupport deviation investigations, CAPA development, and root cause analysis; participate in change control assessments, ensuring proper validation impact evaluation.\n\nReview and approve technical documentation related to manufacturing and quality systems.\n\nCollaborate with engineering and manufacturing functions to ensure quality standards are in place and maintained.\n\nRole/Site Specific Requirements:\n\nThis role is primarily a sedentary role and may require exerting up to 10 pounds of force to move objects.\n\nRequires visual acuity for working with data, figures, computer monitor, extensive reading and general observations of facilities.\n\nParticipation in an occupational health program, including medical assessment, surveillance, vaccination, and testing.\n\nUse of personal protective equipment such as respirators, personal air purifying respirators (PAPR), gowns, gloves, face protection, and other barrier equipment.\n\nExposure:\n\nUse of personal protective equipment including respirators, PAPR, gowns, gloves, face protection, other barrier equipment.\n\nHandling, managing, and disposing hazardous and non‑hazardous waste (chemicals, universal and e‑waste, oil, aqueous wastewater) with potential exposure to bloodborne pathogens.\n\nWorking in laboratories, production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled.\n\nThe items described here are representative of those that must be met to successfully perform the essential functions of this job.\n\nQualifications:\n\nBachelor’s degree in Engineering (Chemical, Electrical, or Mechanical) preferred.\n\nMinimum of 5 years of experience in facilities, equipment, utilities and FDA‑regulated environment.\n\nBonus Qualifications:\n\nProfessional Engineer (PE) or Engineer-in-Training (EIT) preferred.\n\nSalary:\n$100,000 - $110,000 USD\n\nBenefits:\nComprehensive benefits package including employer‑paid healthcare coverage after 30 days of employment, choice of FSA/HSA, parental leave, 401(k) plan with matching contributions. Employees receive free compounded medications for themselves and immediate family members.\n\nEqual Employment Opportunity:\nStrive Pharmacy is an equal‑opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.\n\n#J-18808-Ljbffr","company":"Strive Pharmacy","rawCompany":"strive pharmacy","city":"Florida","state":"NY","isRemote":false,"isActive":false,"createdAt":"2026-07-16T04:08:44.837Z","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":"541330","title":"Engineering Services","slug":"engineering-services"},{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541380","title":"Testing Laboratories and Services","slug":"testing-laboratories-and-services"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Position Type:\nFull-Time\n\nLocation:\nAlachua, FL (Onsite Monday - Friday)\n\nReporting to:\nDirector of Quality\n\nPosition Overview:\nThe Quality Engineer will partner and collaborate with the QA and Engineering teams to ensure that all required qualifications and validations are performed for facilities, systems, software, and equipment, meeting all partner needs in compliance with standard operating procedures. Specific activities include review of study design, protocols, execution and reports associated with equipment and process validation studies; provide review and approval of laboratory method validation and verification; provide technical reviews for Quality risk assessments, investigations and process evaluations for compounding and laboratory equipment as applicable.\n\nKey Responsibilities:\n\nEnsure validation activities comply with cGMP, FDA regulations, ISO standards, and internal quality procedures.\n\nDevelop, review, and approve validation documentation including validation plans, protocols (IQ, OQ, PQ), reports and summary documents.\n\nSupport lifecycle management of validated systems and software, including requalification, change control, and periodic review.\n\nProvide guidance on risk-based validation strategies aligned with industry standards (e.g., GAMP, ICH Q9).\n\nProvide quality engineering support to analytical laboratories.\n\nAssist with equipment validation/verification and troubleshooting activities; support laboratory equipment qualification and lifecycle management.\n\nLead or participate in cross-functional quality improvement projects and drive initiatives related to process optimization, validation efficiency, and quality system improvements.\n\nSupport implementation of new technologies, automation, or process changes requiring validation oversight.\n\nProvide technical expertise during new product introduction (NPI) or process transfer activities.\n\nProvide day-to-day quality engineering support to operations.\n\nSupport deviation investigations, CAPA development, and root cause analysis; participate in change control assessments, ensuring proper validation impact evaluation.\n\nReview and approve technical documentation related to manufacturing and quality systems.\n\nCollaborate with engineering and manufacturing functions to ensure quality standards are in place and maintained.\n\nRole/Site Specific Requirements:\n\nThis role is primarily a sedentary role and may require exerting up to 10 pounds of force to move objects.\n\nRequires visual acuity for working with data, figures, computer monitor, extensive reading and general observations of facilities.\n\nParticipation in an occupational health program, including medical assessment, surveillance, vaccination, and testing.\n\nUse of personal protective equipment such as respirators, personal air purifying respirators (PAPR), gowns, gloves, face protection, and other barrier equipment.\n\nExposure:\n\nUse of personal protective equipment including respirators, PAPR, gowns, gloves, face protection, other barrier equipment.\n\nHandling, managing, and disposing hazardous and non‑hazardous waste (chemicals, universal and e‑waste, oil, aqueous wastewater) with potential exposure to bloodborne pathogens.\n\nWorking in laboratories, production rooms, waste holding areas, or other facilities where hazardous chemicals may be stored or handled.\n\nThe items described here are representative of those that must be met to successfully perform the essential functions of this job.\n\nQualifications:\n\nBachelor’s degree in Engineering (Chemical, Electrical, or Mechanical) preferred.\n\nMinimum of 5 years of experience in facilities, equipment, utilities and FDA‑regulated environment.\n\nBonus Qualifications:\n\nProfessional Engineer (PE) or Engineer-in-Training (EIT) preferred.\n\nSalary:\n$100,000 - $110,000 USD\n\nBenefits:\nComprehensive benefits package including employer‑paid healthcare coverage after 30 days of employment, choice of FSA/HSA, parental leave, 401(k) plan with matching contributions. Employees receive free compounded medications for themselves and immediate family members.\n\nEqual Employment Opportunity:\nStrive Pharmacy is an equal‑opportunity employer that is committed to diversity and inclusion. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.\n\n#J-18808-Ljbffr","datePosted":"2026-07-16T04:08:44.837Z","dateModified":"2026-07-16T04:08:44.837Z","hiringOrganization":{"@type":"Organization","name":"Strive Pharmacy","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Florida","addressRegion":"NY","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"e27fa3061c0da42e279f85cc"},"url":"https://jobsearcher.com/jobs/e27fa3061c0da42e279f85cc"}}