Supervisor, Sterile Operations

Role: Sterile Operations Supervisor overseeing daily sterile drug manufacturing activities within a regulated pharmaceutical/biotech environment. Responsibilities: supervise shift operations including formulation, component prep, isolator filling, inspection, and device assembly; coordinate work schedules, equipment readiness, and personnel training; support equipment validation, process validation, and aseptic process simulations; review batch records and ensure compliance with cGMP, data integrity, and contamination control standards; lead internal audits and support quality investigations and CAPAs. Requirements: Bachelor's in engineering, microbiology, biochemistry, or pharma sciences preferred; 5-7+ years in pharma/biotech manufacturing with 2+ years in supervisory roles; strong knowledge of aseptic processing, contamination control, EU GMP Annex 1, FDA 21 CFR Parts 210/211; proven leadership, technical writing, and cross-functional coordination skills. HighValue: sterile/aseptic operations, cGMP compliance, batch record review, Investigations, media fills, and process validation. WorkSetup: full-time, on-site in a cleanroom environment; physical ability to work in classified areas and handle materials safely.