Process Validation & NRS Operations Coordinator

Job description

The Process Validation (PV) Coordinator is the architect of the scientific chain of custody. This role is mission-critical for the successful execution of Engineering and Process Performance Qualification (PPQ) runs. You will orchestrate the end-to-end lifecycle of Non-Routine Samples (NRS) and Process Validation documentation, ensuring that every milliliter of sample and every line of data is captured with high fidelity. As a key player in OCN’s tech transfer engine, you will bridge the gap between Manufacturing, the Lab, and Quality to ensure "Right First Time" (RFT) validation outcomes for our growing biologics portfolio. The Opportunity: Scientific Sample Stewardship (NRS Management): Orchestration: Lead the Non-Routine Sample (NRS) lifecycle for 2,000L SUT and 16,000L SS tech transfers, ensuring 100% alignment between the PV sampling plan and floor execution. Cold Chain Integrity: Execute high-precision aliquoting, labeling, and flash-freezing operations. You are the guardian of the "Sample-to-Freeze" clock, ensuring hold-time compliance to protect sample stability for CQAs. Logistics & Forecast: Act as the primary liaison between MSAT and Analytical Labs; provide high-accurac...