Sr Manager, Process Engineering
Listed on 2026-09-13
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Manufacturing / Production
Validation Engineer
We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job DescriptionThe Manufacturing Science and Technology (MSAT) Operations & Automation Technology (OAT) Manager / Senior Manager serves as a technical leader supporting clinical cell therapy manufacturing operations. This role partners with Manufacturing, Facilities & Engineering, Quality, Validation, IT, Process Development, and Network MSAT to ensure reliable operation of manufacturing equipment, automation platforms, computerized systems, and data-integrity compliant processes.
The position provides technical support for GMP manufacturing, technology transfers, new product introductions, equipment lifecycle management, automation initiatives, deviation investigations, change controls, and continuous improvement projects. The engineer acts as a key interface between manufacturing operations and technology functions to drive operational excellence, scalability, and innovation.
Key Responsibilities Equipment and Automation Support- Provide technical support for GMP manufacturing equipment and automation systems.
- Lead or support equipment troubleshooting, root-cause investigations, and implementation of corrective actions.
- Support equipment upgrades, software updates, and introduction of new technologies.
- Coordinate with Facilities & Engineering, Validation, IT, and vendors to maintain system reliability.
- Serve as technical SME for assigned manufacturing systems and automation platforms.
- Support clinical manufacturing technology transfers and process introductions.
- Assess equipment readiness, automation requirements, and system impacts associated with new programs.
- Partner with cross-functional teams to ensure successful implementation of manufacturing processes.
- Develop and execute equipment-related readiness plans for new products and process changes.
- Provide technical support during manufacturing campaigns.
- Participate in lot monitoring, escalation management, and rapid issue resolution.
- Evaluate process and equipment performance trends and identify improvement opportunities.
- Support manufacturing readiness activities, batch execution success, and operational reliability.
- Author and review deviations, CAPAs, change controls, risk assessments, and technical reports.
- Support impact assessments associated with equipment, automation, and process changes.
- Ensure activities comply with GMP, data integrity, and regulatory requirements.
- Support audit and inspection readiness activities.
- Drive equipment and automation improvements that increase process robustness and operational efficiency.
- Implement data collection, trending, monitoring, and visualization tools to improve manufacturing performance.
- Evaluate emerging technologies, digital tools, AI solutions, and automation opportunities for clinical manufacturing.
- Support development of…
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