Sr Process Engineer II

Key Responsibilities

• Own and maintain global process documentation, including Process Descriptions, Process Control Strategy, & process FMEAs for multi-site commercial processes
• Conduct global change control impact assessments to ensure process consistency across the network
• Support the development of a standardized documentation and governance framework to enable lifecycle management and harmonization
• Lead high-priority, complex global MSAT projects spanning multiple sites, functions, and jurisdictions
• Contribute to Global MSAT project portfolio strategy, prioritization, and execution
• Drive cross-functional alignment and ensure reliable execution of network-level initiatives
• Lead global investigations across sites to identify root causes and implement sustainable solutions
• Develop and implement standard investigation frameworks and playbooks
• Ensure adherence to global governance and change management processes to support process harmonization
• Act as a site-agnostic process expert, supporting alignment of site activities with network strategy
• Partner with Manufacturing, Process Development, and Quality to bridge development and commercial operations
• Support process harmonization and implementation of best practices across sites

Core Competencies

• Technical depth & process expertise in late-stage clinical and commercial T cell and viral vector manufacturing
• Leadership without authority across a matrixed, global organization
• Excellent interpersonal, verbal and written communication skills, presentation skills, as well as digital literacy
• Strong understanding of GMP environment and change control processes
• Experience in Project Management and Project Management Methodology
• Experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis)
• Proactive and willing to accept temporary responsibilities outside of initial job description
• Experience in engineering in highly regulated manufacturing environments

Basic Qualifications

• Bachelor's Degree in Engineering, Biotechnology or Life Sciences with at least 8 years of relevant experience
• Masters in Engineering, Biotechnology or Life Sciences with at least 6 years of relevant experience

Preferred Qualifications

• Expertise in process equipment and engineering, technology transfer or pharmaceutical manufacturing experience
• Expertise in viral vector manufacturing is a plus
• Cell culture, cell therapy or aseptic processing experience
• Equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation
• Experience in Project Management and Project Management Methodology
• Strong understanding of GMP environment and change control processes
• Experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis)
• Proactive and willing to accept temporary responsibilities outside of initial job description
• Experience in engineering in highly regulated manufacturing environments

Benefits

The salary range for this position is: $153,935.00 - $199,210.00. 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 include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing.

For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

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