Aseptic Processing Engineer

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.