Manufacturing Operation Specialist I

About the Role

This role will be responsible for safe, compliant, and accurate manufacturing, including coating, purification, and packaging of Corning’s dissolvable microcarrier products (DMC). The successful candidate will execute multi-step chemical and polymer processes per validated procedures, maintain GMP documentation, and ensure product quality, safety, and traceability throughout production. What You'll Do

• 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, changeovers, cleaning, line opening, and line clearance activities.

• Perform 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.

• Packout & 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.

• Quality & Regulatory Compliance: comply with GMP, ISO, and site-specific quality system requirements; perform required in-process inspections and quality checks; monitor product for defects; maintain accurate, complete, and contemporaneous documentation including batch records, logs, and signatures; identify and segregate non-conforming materials and initiate DMRs per procedure; ensure lot number designation, traceability, and documentation accuracy.

• Safety & Environmental Compliance: follow all lab and job-specific safety requirements; properly use PPE and demonstrate correct gowning practices for production areas; safely handle, collect, and dispose of chemicals in coordination with Safety and HAZMAT requirements; report unsafe conditions, equipment malfunctions, or unusual events to supervision immediately.

• Collaboration & Continuous Improvement: work collaboratively with other functions meet production and quality goals; escalate issues appropriately and request technical support when needed; support process improvements, troubleshooting, and validation activities; interact professionally with colleagues. What We're Looking For

• Experience working with GMP, ISO, and site-specific quality systems; ability to perform in-process inspections and quality checks; monitor product for defects.

• Experience with cleaning and equipment readiness; labware cleaning and depyrogenation processes; ability to complete cleaning logs, inspections, and startup documentation.

• Ability to perform multi-step chemical and polymer processes in accordance with validated procedures; maintain accurate, complete documentation including batch records, logs, and signatures.

• Strong emphasis on lot number designation, traceability, and documentation accuracy; ability to collaborate effectively with cross-functional teams.

• Commitment to safety, proper PPE use, and adherence to gowning practices; knowledge of handling and disposal of chemicals per safety/HAZMAT requirements. Compensation & Benefits

(Salary range, benefits, and perks are not specified in the posting.)