MES Validation Specialist - MSAT Process 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, a Gilead Company, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

Job Description

This role is for a MES Validation Specialist (MSAT Process Engineer) at Kite, a Gilead Company.

About the role

As an MSAT Process Engineer focused on MES Validation, you will be the MES SME for risk-based validation and lifecycle management of PAS-X EBRs with knowledge of connected GMP systems (e.g., ERP/EBS). You will lead cross-functional validation strategy and execution for changes and new implementations, ensure end-to-end data integrity and participate in inspections on computerized systems within a commercial cell-therapy manufacturing environment. This is a senior individual-contributor role operating with minimal direction and broad influence across MSAT, Manufacturing and Quality.

Your Responsibilities

MES Validation Expertise & Strategy

• Own the site MES Computerized System Validation (CSV) approach (risk-based per GAMP 5/Annex 11/21 CFR Part 11); define validation deliverables, traceability, and acceptance criteria for EBR recipe changes and new recipe implementations.
• Establish and maintain testing strategies and evidence for MES (recipe) releases.
• Coach/mentor engineers and stakeholders (MFG, QA, IT/OAT) on validation best practices, ensuring consistent understanding of validation requirements while ensuring effective documentation delivery.
• Act as SME in inspections (FDA/EMA) for MES; ensure inspection readiness (complete V-model documentation set).

EBR Recipe Lifecycle Management

• Translate business requirements into robust EBR designs; design, lead reviews, versioning, approvals, and controlled retirements; manage cut-overs to production.
• Execute on MES validation for updated and new EBR designs.
• Drive standardization and re-use of design elements (basic operations, formulas, ERP integration patterns) and author/update SOPs, work instructions, and training materials.
• Keep knowledge up to date with the MES application.

Data Integrity & Interfaces

• Ensure complete, accurate, and attributable data flows between MES and interfacing equipment or systems; lead resolution of cross-system discrepancies and data integrity issues.

Operational Support & Continuous Improvement

• Provide on-call/escalation support for MES incidents impacting manufacturing continuity; drive root-cause analysis and sustainable fixes through deviation, change control and CAPA processes.
• Identify, prioritize, and execute improvement projects that reduce validation effort while improving compliance (templates, risk assessments, automation of evidence capture).

MES Network & Cross-site alignment

• Represent the site in the global MES network; drive alignment on best practices and methodologies.

Your Profile

Education

Bachelor’s degree or equivalent experience.

Knowledge and Experience

• 5+ years experience in GMP manufacturing with hands-on MES/EBR design, validation, and operations experience.
• Strong working knowledge of PAS-X (v3.x); ability to author URS/FS/CS, risk assessments, test protocols/reports and other GMP compliant documentation.
• Deep familiarity with GAMP 5, EU Annex 11, and 21 CFR Part 11; ability to apply risk-based validation and defend evidence in audits.
• Excellent knowledge of manufacturing operations.
• Knowledge of Oracle EBS / SAP S/4 HANA is a plus.
• Knowledge of OSI-PI is a plus.
• SQL/XML familiarity for MES data queries as well as basic scripting or test automation is a plus.

Personal Skills

• Operates with minimal direction, plans own work, and influences long-range objectives; mentors others and elevates team standards.
• Clear, concise technical writing and stakeholder communication.
• Ability to work in a dynamic environment with fast changing priorities.
• Ability to think critically and demonstrated problem-solving and troubleshooting skills.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
• Fluent English language skills.

Additional requirements

• Ability to provide on-call support outside office hours when required.
• Only candidates in possession of a valid EU work permit will be considered.

About Kite

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.