The Process Engineer III- Data Analytics provides process and data analytics expertise to support manufacturing operations, investigations, process monitoring, and continuous improvement. This role enables real-time manufacturing decision-making through advanced analytics and scalable data solutions. This role also ensures strong alignment between site operations and network/global analytics teams, supporting current and future manufacturing and data analytics needs.

Key Responsibilities:

Continued Process Verification (CPV) & Manufacturing Analytics

•Enable real-time, data-driven decision-making for manufacturing operations, CPV, and investigations

•Monitor CPPs, CQAs, and IPCs to identify trends, process variability, and emerging risks

•Lead data analysis for deviations, OOT/OOS, and complex investigations to support timely and effective decision- making

Statistical & Advanced Analytics

•Apply and standardize statistical methods (SPC, regression, multivariate analysis) to evaluate process performance and variability

•Support predictive analytics for process understanding and risk evaluation

•Ensure analytical methods and outputs are robust, fit for purpose, and compliant for operational and regulatory decision-making

Automation & Data Systems

•Drive development of dashboards, automation, and data pipelines to improve efficiency and scalability

•Enable real-time monitoring through integration of MES, LIMS, and data platforms

•Standardize and streamline analytics workflows to reduce manual effort and improve consistency

Process Engineering:

•Lead cross-functional teams to perform root-cause investigations and deviation resolution.

•Monitor process performance and identify improvement opportunities

•Assess the impact of process changes on process performance and product quality.

•Author and review manufacturing documentation and technical reports, as needed.

•Lead continuous improvement initiatives.

•Support regulatory inspections.

•Partner with Manufacturing, Quality, and Network to resolve process issues.

•Other duties may include floor support, technology transfers, and Lifecycle management activities

Leadership & Capability Building

•Coach in statistics, data interpretation, and analytics tools to junior team members

•Support development of standardized analytics tools and methods

•Ensure compliance with data integrity, GMP, and regulatory expectations

•Support CPV and inspections with defensible analytics

Basic Qualifications:

•Bachelor's degree in engineering, Statistics, Data Science, or related field

•Experience leading investigations, authoring technical reports, and operating within a cGMP manufacturing environment.

•Experience in manufacturing analytics, CPV, or process monitoring (GMP environment preferred)

•Strong knowledge of applied statistics (SPC, regression, multivariate analysis)

•Experience with analytics tools and dashboards (e.g., JMP, SQL, visualization tools –Tableau, Spotfire, Quicksight)

•Experience in computer system validation

•Experience working cross-functionally in manufacturing and quality environments

Preferred Qualifications:

•Knowledge of cell therapy manufacturing processes and CAR-T products preferred.

•Experience with automation, dashboards, and data pipelines

•Familiarity with MES, LIMS, GPDL, or data platform integrations

•Experience with predictive modeling, machine learning (ML), and AI-enabled solutions for manufacturing and process monitoring

•Experience working with network/global teams or cross-site initiatives

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.