Clean Room Manufacturing Operator 2

Role: Manufacturing Operator II in biopharma collagen production, responsible for pre- and post-formulation processing, equipment operation, and cleanroom activities. Responsibilities include blending, mixing, pouring, loading, inspection, packaging, and chemical processing such as crosslinking, all performed in ISO Class 5 or 7 environments under GMP and QSR standards. Maintains accurate records, interfaces with QA/QC, and ensures compliance with SOPs and safety protocols. Requirements: High School diploma (science degree a plus), 2+ years in chemical processing or batch mixing within medical device or pharmaceutical manufacturing, experience in cleanroom settings, and proficiency in GMP/QSR compliance. Skills include equipment troubleshooting, precise measurement, gowning qualification, and teamwork. Preferred candidates will possess familiarity with lyophilizers, autoclaves, and analytical tools, and be able to work flexible shifts, including overtime. Physical ability to lift up to 60 lbs, stand for 8 hours, and gown to ISO standards is necessary. The role is a first shift (7:00 a.m. - 3:30 p.m.), in a regulated manufacturing environment focused on collagen-based biomaterials. Experience in GMP regulated environments, with attention to quality and safety, is essential.