Process Validation & NRS Operations Coordinator

Roche • Oceanside, CA

1d • Onsite

About The Position

The Process Validation (PV) Coordinator is responsible for establishing the scientific chain of custody, which is critical for the successful execution of Engineering and Process Performance Qualification (PPQ) runs. This role involves orchestrating the entire lifecycle of Non-Routine Samples (NRS) and Process Validation documentation, ensuring that every sample and data point is captured with high fidelity. As a key contributor to OCN’s tech transfer engine, the coordinator will serve as a liaison between Manufacturing, the Lab, and Quality departments to ensure "Right First Time" (RFT) validation outcomes for the company's expanding biologics portfolio.

Requirements

• A foundational understanding of biopharmaceutical unit operations (Cell Culture, Chromatography, Ultrafiltration).
• Understanding why a sample is being pulled, not just when.
• Expert-level proficiency in Smartsheet and SharePoint.
• A strong appetite for "Everyday AI" and automation tools to replace manual tracking.
• Demonstrated ability to manage "The Handshake"—managing the complex logistics between Manufacturing (who pull the sample), Materials Management (who ship the sample), and Labs (who test the sample).
• High "Detail Orientation" is non-negotiable.
• A desire to understand the "Physics of the Process" to better predict where the sampling or documentation workflow might fail.
• Bachelor’s degree in Chemical Engineering, Bioengineering, or Life Sciences and a minimum of 2-4 years of related/relevant experience; or Master's degree in Chemical Engineering, Bioengineering, or Life Sciences with 0-2 years of equivalent work experience.

Responsibilities

• 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.
• Execute high-precision aliquoting, labeling, and flash-freezing operations, safeguarding the "Sample-to-Freeze" clock and ensuring hold-time compliance to protect sample stability for CQAs.
• Act as the primary liaison between MSAT and Analytical Labs, providing high-accuracy testing forecasts to ensure lab capacity is reserved for critical PV windows.
• Maintain a robust sample tracking and shipping system to comply with global regulatory requirements and internal Data Integrity standards.
• Partner with PV leads to drive the on-time delivery of Validation Protocols and Summary Reports.
• Identify bottlenecks in the "author-to-approver" flow and escalate proactively to prevent PPQ delays.
• Maintain and continuously improve the PV Playbook, incorporating "lessons learned" from every tech transfer to ensure the OCN site remains a center of excellence for validation.
• Facilitate the seamless flow of analytical results from the LIMS/Testing labs back to the study authors, ensuring data is contextualized and ready for statistical analysis.
• Actively drive the transition of PV tracking from manual tools (e.g., gDocs/Spreadsheets) to standardized digital platforms (e.g., Smartsheet, DReAM AF/EF, or Tulip).
• Develop and report on KPIs for Validation Readiness, such as "Sample RFT Rate" and "Document Cycle Time," to support the site’s Digital Performance Monitoring (DPM) goals.
• Lead Kaizen events or "Continuous Improvement" sprints to reduce waste in the sample management workflow (e.g., optimizing kit assembly for SUT facilities).

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees