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-accuracy testing forecasts to ensure lab capacity is reserved for critical PV windows.
Chain of Custody: Maintain a "bulletproof" sample tracking and shipping system to comply with global regulatory requirements and internal Data Integrity standards.
Validation Documentation & Lifecycle Management
Document Velocity: 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.
Playbook Evolution: 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.
Data Transfer: 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.
Digital & Business Process Optimization
Digital Transformation: 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).
Metrics & Performance: 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.
Lean Execution: Lead Kaizen events or "Continuous Improvement" sprints to reduce waste in the sample management workflow (e.g., optimizing kit assembly for SUT facilities).
Knowledge, Skills, and Abilities
Technical Fluency: A foundational understanding of biopharmaceutical unit operations (Cell Culture, Chromatography, Ultrafiltration). You should understand why a sample is being pulled, not just when.
Digital Native: Expert-level proficiency in Smartsheet and SharePoint. A strong appetite for "Everyday AI" and automation tools to replace manual tracking.
Project Orchestration: 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).
Attention to Detail: In the world of Validation, a transposed digit on a label is a deviation. High "Detail Orientation" is non-negotiable.
Intellectual Curiosity: A desire to understand the "Physics of the Process" to better predict where the sampling or documentation workflow might fail.
Who you are
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.
Relocation benefits are not available for this posting
The expected salary range for this position based on the primary location of California is $78,900-$146,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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