{"schemaVersion":"jobsearcher.job.v1","id":"fdfbbfb51e133a3f4c5a009a","url":"https://jobsearcher.com/jobs/fdfbbfb51e133a3f4c5a009a","canonicalUrl":"https://jobsearcher.com/jobs/fdfbbfb51e133a3f4c5a009a","title":"Upstream Process Engineer","description":"Azzur Group San Francisco is looking for Senior Upstream Process Engineer to join our team. Working with a multi-disciplinary team, the Sr process engineer ensures fulfillment of process characterization for our client according to the established plan. In this hands-on role, the Sr. process engineer is the key liaison between client’s product and CMO, and will be responsible for the quality of work produced by their team. Experience with cGMP and FDA compliance is essential.\nEssential Duties and Responsibilities\nFunction as SME and lead technical team at CMDO for late phase recombinant protein drug development for both Drug Substance and Drug Product, including tech transfer, scale up, gap/risk analysis, process characterization/qualification, cGMP manufacturing.\nProvide technical guidance and keep project on time and in compliance with cGMP regulations.\nReview and approve controlled documents including batch records, SOPs, protocols, and reports related to process development and characterization.\nWork closely with QA/QC to identify and evaluate deviations, CAPA and change control.\nLead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants.\nEnsure compliance with both internal client’s process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.\nCollaborate with CDMO for health authority inspection.\nResponsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.\nActively participate as member of client’s representative supporting product and new business development.\nParticipate for US and International specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.\n\nRequired Experience\nBS Engineering or related discipline.\nMinimum 10 years’ process engineering experience in the upstream pharmaceutical and/or biotechnology industry is required.\nExperience with FDA compliance and cGMP is required.\nMust be results oriented with several years of hands-on experience, familiar with industry concepts, practices and procedures in a cGMP environment.\nMust have experience reviewing batch record\nMust have experience working with CHO\nExcellent verbal, oral, and technical writing communication skills.\nProficient in Microsoft Word, Excel, Power Point, and able to quickly learn new computer applications.\nAzzur Core Values:\nPuts Others First...Have the Courage to Take Action…Take Personal Responsibilities…Have Fun!\n\nThis employer participates in E-Verify.","company":"Azzur Group","rawCompany":"azzur group","city":"Seattle","state":"WA","isRemote":false,"isActive":false,"createdAt":"2026-04-12T20:59:41.784Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Upstream Process Engineer","description":"Azzur Group San Francisco is looking for Senior Upstream Process Engineer to join our team. Working with a multi-disciplinary team, the Sr process engineer ensures fulfillment of process characterization for our client according to the established plan. In this hands-on role, the Sr. process engineer is the key liaison between client’s product and CMO, and will be responsible for the quality of work produced by their team. Experience with cGMP and FDA compliance is essential.\nEssential Duties and Responsibilities\nFunction as SME and lead technical team at CMDO for late phase recombinant protein drug development for both Drug Substance and Drug Product, including tech transfer, scale up, gap/risk analysis, process characterization/qualification, cGMP manufacturing.\nProvide technical guidance and keep project on time and in compliance with cGMP regulations.\nReview and approve controlled documents including batch records, SOPs, protocols, and reports related to process development and characterization.\nWork closely with QA/QC to identify and evaluate deviations, CAPA and change control.\nLead and direct the work of our partner organizations and consultants. Build strong communications and relationships with partner organizations and consultants.\nEnsure compliance with both internal client’s process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.\nCollaborate with CDMO for health authority inspection.\nResponsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.\nActively participate as member of client’s representative supporting product and new business development.\nParticipate for US and International specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.\n\nRequired Experience\nBS Engineering or related discipline.\nMinimum 10 years’ process engineering experience in the upstream pharmaceutical and/or biotechnology industry is required.\nExperience with FDA compliance and cGMP is required.\nMust be results oriented with several years of hands-on experience, familiar with industry concepts, practices and procedures in a cGMP environment.\nMust have experience reviewing batch record\nMust have experience working with CHO\nExcellent verbal, oral, and technical writing communication skills.\nProficient in Microsoft Word, Excel, Power Point, and able to quickly learn new computer applications.\nAzzur Core Values:\nPuts Others First...Have the Courage to Take Action…Take Personal Responsibilities…Have Fun!\n\nThis employer participates in E-Verify.","datePosted":"2026-04-12T20:59:41.784Z","dateModified":"2026-04-12T20:59:41.784Z","hiringOrganization":{"@type":"Organization","name":"Azzur Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Seattle","addressRegion":"WA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"fdfbbfb51e133a3f4c5a009a"},"url":"https://jobsearcher.com/jobs/fdfbbfb51e133a3f4c5a009a"}}