Process Engineer III- Data Analytics
About the role
We’re here for one reason – to cure cancer. 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, ensuring strong alignment between site operations and network/global analytics teams to support current and future manufacturing and data analytics needs.
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.
- Provide floor support, technology transfers, and Lifecycle management activities as needed.
- Leadership & Capability Building
- Coach junior team members in statistics, data interpretation, and analytics tools.
- Support development of standardized analytics tools and methods.
- Ensure compliance with data integrity, GMP, and regulatory expectations.
- Support CPV and inspections with defensible analytics.
Requirements
- 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.
- 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.
Pay
The salary range for this position is $115,260.00 - $149,160.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: Gilead Careers - Compensation, Benefits and Wellbeing.