{"schemaVersion":"jobsearcher.job.v1","id":"46ff2b14fd554dc6187de927","url":"https://jobsearcher.com/jobs/46ff2b14fd554dc6187de927","canonicalUrl":"https://jobsearcher.com/jobs/46ff2b14fd554dc6187de927","title":"Process Engineer II, Process Development","description":"Process Engineer II, Process Development - Boca Raton, FL\n\nPosition Summary\nThe Process Engineer II provides process development and transfer expertise for IgG Immunotherapy Production. Provides updates to PD Management team on a regular basis to ensure compliance issues are met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model. As a key member of the PD group, supports Manufacturing, QC/QA, and Regulatory departments.\n\nEssential Functions and Responsibilities\n\nProvide support for technical issues related to the manufacturing process and product quality.\n\nDevelop new processes for production of plasma-derived therapies.\n\nBe familiar with regulatory guidelines regarding process development/validation and implementing manufacturing process changes.\n\nOptimize and maintain compliance in PD laboratory by ensuring equipment calibration, IQ/OQ/PM status are current.\n\nDesign and plan scientific experiments to achieve corporate goals for existing projects. Write protocols and reports in support of PD studies.\n\nReview and/or approve cGMP documentation generated by other PD group members as necessary.\n\nLead execution of process development/evaluation studies and process validations using a qualified scale down model.\n\nBe responsible for transferring process changes and/or new processes from PD to Manufacturing.\n\nAct as liaison between PD and Manufacturing for supporting deviations and investigations and for transferring new or optimized processes.\n\nMaintain and review process development batch records for scale down process models.\n\nPerform other activities as assigned by the PD Managers.\n\nSupport Manufacturing, Engineering, and Quality Management departments with development and implementation of new process/technology.\n\nAssist manufacturing personnel in the execution of process development and process validation studies in a cGMP production environment as needed.\n\nJob Competencies\n\nAbility to follow cGMPs and procedures with great attention to detail.\n\nAbility to work in a high-pressure, deadline-driven environment.\n\nDemonstrated ability to achieve goals, overcome obstacles, and meet deadlines.\n\nManage time and balance multiple assignments.\n\nExcellent oral and written communication skills with close attention to detail and accuracy.\n\nEducation Requirements\n\nBachelor’s degree in Science or Engineering required.\n\nExperience Requirements\n\nMinimum of five (5) years in a cGMP, pharmaceutical/biological manufacturing environment required.\n\nFamiliarity with aspects of process development.\n\nKnowledge of FDA cGMP requirements.\n\nPreferred Experience\n\nPreferred experience in process validation, scale-down models, and transfer.\n\nBenefits\n\n401K plan with employer match and immediate vesting.\n\nMedical, Vision, Life and Dental Insurance.\n\nPet Insurance.\n\nCompany-paid STD and LTD.\n\nCompany-paid holidays.\n\n3 weeks paid time off (within the first year).\n\nTuition assistance (after the first year).\n\nConvenient location near Tri-Rail.\n\nFree shuttle to the Boca Tri-Rail station.\n\nADMA Biologics uses E-Verify to confirm employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit https://www.dhs.gov/E-Verify.\n\nADMA Biologics is an Equal Opportunity Employer.\n\n#J-18808-Ljbffr","company":"Initial Therapeutics","rawCompany":"initial therapeutics","city":"Boca Raton","state":"FL","isRemote":false,"isActive":true,"createdAt":"2026-06-17T03:31:36.355Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-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":"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":"Process Engineer II, Process Development","description":"Process Engineer II, Process Development - Boca Raton, FL\n\nPosition Summary\nThe Process Engineer II provides process development and transfer expertise for IgG Immunotherapy Production. Provides updates to PD Management team on a regular basis to ensure compliance issues are met. Responsible for maintaining compliance in PD laboratory and executing process development/evaluation studies as well as process validations using a scale down model. As a key member of the PD group, supports Manufacturing, QC/QA, and Regulatory departments.\n\nEssential Functions and Responsibilities\n\nProvide support for technical issues related to the manufacturing process and product quality.\n\nDevelop new processes for production of plasma-derived therapies.\n\nBe familiar with regulatory guidelines regarding process development/validation and implementing manufacturing process changes.\n\nOptimize and maintain compliance in PD laboratory by ensuring equipment calibration, IQ/OQ/PM status are current.\n\nDesign and plan scientific experiments to achieve corporate goals for existing projects. Write protocols and reports in support of PD studies.\n\nReview and/or approve cGMP documentation generated by other PD group members as necessary.\n\nLead execution of process development/evaluation studies and process validations using a qualified scale down model.\n\nBe responsible for transferring process changes and/or new processes from PD to Manufacturing.\n\nAct as liaison between PD and Manufacturing for supporting deviations and investigations and for transferring new or optimized processes.\n\nMaintain and review process development batch records for scale down process models.\n\nPerform other activities as assigned by the PD Managers.\n\nSupport Manufacturing, Engineering, and Quality Management departments with development and implementation of new process/technology.\n\nAssist manufacturing personnel in the execution of process development and process validation studies in a cGMP production environment as needed.\n\nJob Competencies\n\nAbility to follow cGMPs and procedures with great attention to detail.\n\nAbility to work in a high-pressure, deadline-driven environment.\n\nDemonstrated ability to achieve goals, overcome obstacles, and meet deadlines.\n\nManage time and balance multiple assignments.\n\nExcellent oral and written communication skills with close attention to detail and accuracy.\n\nEducation Requirements\n\nBachelor’s degree in Science or Engineering required.\n\nExperience Requirements\n\nMinimum of five (5) years in a cGMP, pharmaceutical/biological manufacturing environment required.\n\nFamiliarity with aspects of process development.\n\nKnowledge of FDA cGMP requirements.\n\nPreferred Experience\n\nPreferred experience in process validation, scale-down models, and transfer.\n\nBenefits\n\n401K plan with employer match and immediate vesting.\n\nMedical, Vision, Life and Dental Insurance.\n\nPet Insurance.\n\nCompany-paid STD and LTD.\n\nCompany-paid holidays.\n\n3 weeks paid time off (within the first year).\n\nTuition assistance (after the first year).\n\nConvenient location near Tri-Rail.\n\nFree shuttle to the Boca Tri-Rail station.\n\nADMA Biologics uses E-Verify to confirm employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit https://www.dhs.gov/E-Verify.\n\nADMA Biologics is an Equal Opportunity Employer.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:31:36.355Z","dateModified":"2026-06-17T03:31:36.355Z","hiringOrganization":{"@type":"Organization","name":"Initial Therapeutics","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Boca Raton","addressRegion":"FL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"46ff2b14fd554dc6187de927"},"url":"https://jobsearcher.com/jobs/46ff2b14fd554dc6187de927"}}