{"schemaVersion":"jobsearcher.job.v1","id":"788abae797c5c1c1f21fba24","url":"https://jobsearcher.com/jobs/788abae797c5c1c1f21fba24","canonicalUrl":"https://jobsearcher.com/jobs/788abae797c5c1c1f21fba24","title":"Aseptic Processing Engineer","description":"Contract Engineering Resource Summary — Aseptic Processing EngineerSeeking a part-time Aseptic Processing Engineer to support feasibility and risk reduction for a prototype clinical assembly line, with potential for follow-on work.Key Responsibilities:Define contamination-control strategies for two aseptic assembly approaches.Develop process, equipment, and BSC (Biosafety Cabinet) requirements.Author feasibility deliverables, user/process requirements, control strategies, and pFMEAs.Define handling and contamination-control requirements for pre-sterilized components.Translate feasibility outcomes into engineering requirements and readiness recommendations.Required Experience:Hands-on aseptic processing in pharma or medical devices (fill/finish, aseptic assembly, or aseptic connections).Strong knowledge of EU GMP Annex 1, ISO 5/Grade A environments, BSCs, environmental monitoring, and contamination-control principles.Practical understanding of microbiology and sterilization concepts, including bioburden, log reduction, and contamination risk assessment.Ideal Candidate:A hands-on aseptic process engineer with strong technical documentation skills who can produce clear process requirements, risk assessments, and feasibility recommendations while collaborating with vendors, SMEs, and cross-functional teams.","company":"Intellectt","rawCompany":"intellectt","city":"Wi","state":"SD","isRemote":false,"isActive":false,"createdAt":"2026-08-03T11:00:39.493Z","occupations":[{"code":"31-9093.00","title":"Medical Equipment Preparers","slug":"medical-equipment-preparers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"industries":[{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Aseptic Processing Engineer","description":"Contract Engineering Resource Summary — Aseptic Processing EngineerSeeking a part-time Aseptic Processing Engineer to support feasibility and risk reduction for a prototype clinical assembly line, with potential for follow-on work.Key Responsibilities:Define contamination-control strategies for two aseptic assembly approaches.Develop process, equipment, and BSC (Biosafety Cabinet) requirements.Author feasibility deliverables, user/process requirements, control strategies, and pFMEAs.Define handling and contamination-control requirements for pre-sterilized components.Translate feasibility outcomes into engineering requirements and readiness recommendations.Required Experience:Hands-on aseptic processing in pharma or medical devices (fill/finish, aseptic assembly, or aseptic connections).Strong knowledge of EU GMP Annex 1, ISO 5/Grade A environments, BSCs, environmental monitoring, and contamination-control principles.Practical understanding of microbiology and sterilization concepts, including bioburden, log reduction, and contamination risk assessment.Ideal Candidate:A hands-on aseptic process engineer with strong technical documentation skills who can produce clear process requirements, risk assessments, and feasibility recommendations while collaborating with vendors, SMEs, and cross-functional teams.","datePosted":"2026-08-03T11:00:39.493Z","dateModified":"2026-08-03T11:00:39.493Z","hiringOrganization":{"@type":"Organization","name":"Intellectt","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Wi","addressRegion":"SD","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"788abae797c5c1c1f21fba24"},"url":"https://jobsearcher.com/jobs/788abae797c5c1c1f21fba24"}}