MES Validation Specialist MSAT Process Engineer

Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were 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 Description

MES Validation Specialist (MSAT Process Engineer)

Kite a Gilead Company

At Kite we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment where we make discoveries every day discoveries that include our own capabilities and our individual potential.

Were currently seeking to recruit highly motivated talents for different positions to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.

About the role

As 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. You will be joining a team in which employees of all backgrounds and experiences are respected and where working together focused on saving lives by finding the cure for cancer is a daily activity. 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 (riskbased 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 Vmodel documentation set).

EBR Recipe Lifecycle Management

• Translate business requirements into robust EBR designs; design lead reviews versioning approvals and controlled retirements; manage cutovers 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 crosssystem discrepancies and data integrity issues

Operational Support & Continuous Improvement

• Provide oncall/escalation support for MES incidents impacting manufacturing continuity; drive rootcause 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

Bachelors degree or equivalent experience

Knowledge and Experience

• 5 years experience in GMP manufacturing with handson MES/EBR design validation and operations experience

• Strong working knowledge of PASX (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 riskbased 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 longrange 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 oncall support outside office hours when required.

• Only candidates in possession of a valid EU work permit will be considered.

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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.