Senior Process Engineer

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.

Summary:

The Senior Process Engineer is responsible for the design, commissioning, and operation of the KKNA Manufacturing Facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. You will be responsible for helping start up the new state-of-the-art facility, delivering reliable and compliant equipment and systems used in manufacturing to drive the site objectives and align to regional and global standards. As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

Essential Functions:

Technical Skills, Knowledge, and Experience

• Provide hands-on support and guidance for the installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility. • Assume system ownership within Downstream Processing, maintaining cradle-to-grave accountability from design through operations acceptance. • Draft, review, and approve documentation, including operating procedures, maintenance plans, engineering drawings, and equipment specifications. • Participate in Operational Readiness (OR) planning and execution. • Collaborate with Manufacturing, Manufacturing Sciences, and Automation to evaluate and support new product introductions. • Support preparation of maintenance, calibration, and qualification plans. • Manage technical and engineering changes through the change control process. • Support manufacturing operations through process fit assessments, troubleshooting, root cause analysis of nonconformances, and the implementation of process changes and improvements. • Drive continuous improvement of drug substance manufacturing processes through technological innovation. • Actively support inspections and audits conducted by U.S. and other applicable regulatory agencies. • Ensure compliance with applicable regulatory requirements and external standards, including EHS requirements, corporate procedures, and GxP expectations.

Requirements:

Education

Bachelor’s degree in Chemical, Mechanical, Biotechnology Engineering, or a related field.

Experience

• Minimum 5 years’ experience as a process engineer in Pharma, Biopharma, and/or Life Science industries in a manufacturing/operations role. • Knowledge and experience of Single Use Technology (SUT), preferably in monoclonal antibody (mAb) processing. Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues related to both clinical and commercial manufacturing. • Experience with starting up and operating a biopharma manufacturing facility is a plus.

Technical Skills

Proficient in MS Office Suite.

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and adjust course quickly. Strong interpersonal and written/verbal communication skills; strong work ethic; and attention to detail with excellent…