Manufacturing Operation Specialist II

Job title: Manufacturing Operation Specialist II

About the Role

This role will be responsible for safe, compliant, and accurate manufacturing, including coating, purification, sterilization support, packaging, and shipment preparation of Corning's dissolvable microcarrier products (DMC). It also covers raw material receiving, on-site product transportation, post-sterilization inventory management, and maintaining accurate inventory records. The role requires executing multi-step chemical and polymer processes in accordance with validated procedures, maintaining GMP documentation, performing equipment cleaning and setup, and ensuring product quality, safety, traceability, and inventory accuracy throughout production and distribution.

What You'll Do

• Manufacturing & Processing: Manufacture dissolvable microcarriers, including bead production, inspection, and packaging. Prepare, calculate, mix, and verify chemical solutions and reagents within validated guidelines. Perform multi-step synthesis and coating operations following approved procedures. Assist with equipment setup, adjusting, changeovers, cleaning, line opening, and line clearance activities.
• Raw Material Receiving & Handling: Receive raw materials and verify incoming materials against purchase orders, delivery documentation, and approved specifications. Inspect raw materials and packaging for damage, labeling accuracy, quantity, and compliance with site requirements. Document raw material receipt activities in accordance with GMP and inventory control procedures. Transfer received raw materials to designated quarantine, storage, or production areas using approved material handling practices. Support material status identification, traceability, and inventory transactions in applicable systems.
• Cleaning & Equipment Readiness: Perform and document deep cleaning of manufacturing equipment, reactors, pumps, and associated systems. Execute labware cleaning and depyrogenation processes per established procedures. Complete cleaning logs, inspections, and startup documentation to ensure equipment readiness and traceability. Maintain work areas and equipment in a clean, safe, and orderly condition.
• Packout & Sterilization Support & Final Product Preparation: Package dissolvable microcarriers into vials and bags per approved packing instructions. Perform drying, purging, filling, sealing, labeling, and packaging activities. Accurately complete all packout-related data collection and batch documentation. Prepare finished goods for sterilization in accordance with approved procedures and batch requirements. Support sterilization-related material handling, documentation, identification, and product segregation.