Computer System Validation Engineer III at Kyowa Kirin North America

At Kyowa Kirin, we are driven by a singular mission to translate science into smiles. As a global specialty pharmaceutical company based in Japan, we focus on discovering and delivering novel medicines for rare diseases and complex hematologic conditions. We work across the entire spectrum of drug development, from initial discovery to commercialization, ensuring that patients receive life-changing therapies where no other options exist. Our North American team is growing rapidly, and we are looking for passionate individuals to join us in our mission to improve lives through innovation.

The opportunity

We are seeking a Computer System Validation Engineer III to join our team in Sanford, North Carolina. This is a critical, full-time, on-site role where you will support all commissioning, qualification, and verification activities for our manufacturing facility. You will play a key part in our transition from project implementation to routine operations, ensuring our systems remain compliant and effective. Reporting to the Site EQV/CSV Lead, you will serve as an individual contributor who helps shape our technical landscape while fostering a supportive and inclusive culture.

A day in the life

• You will lead the development and maintenance of our site-wide validation programs, ensuring all initiatives align with global computer system validation requirements and industry best practices.
• You will drive the implementation and qualification of essential analytical systems and integrations, including LIMS, Veeva, and various automation platforms.
• You will oversee the ongoing maintenance and continuous improvement of qualified computerized systems to ensure strict compliance with cGMP standards and data integrity regulations.

Who you are

You are a senior-level professional with a strong technical background and a commitment to quality. You possess a bachelor’s degree in a technical field and bring at least 5 years of experience in CQV for biopharmaceutical manufacturing or capital projects. You are fluent in English and have a deep understanding of cGMP regulations, GAMP, and data integrity guidance. You are comfortable working with MS Office and have familiarity with cloud environments and various automation tools. Beyond your technical expertise, you are a collaborative communicator who thrives in fast-paced environments and approaches challenges with resilience and a focus on the needs of our patients.

Why you'll love it here

We believe in rewarding our team members for their hard work and dedication. The anticipated salary for this position is $106,300 to $138,800, depending on your experience and qualifications. In addition to competitive pay, we offer a robust benefits package designed to support your well-being and professional growth:

• 401k plan with company matching.
• Discretionary profit sharing and an annual bonus program.
• Comprehensive medical, dental, and vision insurance.
• Life and disability insurance.
• Generous paid time off, including summer and winter shut-downs.
• Tuition reimbursement to support your continuous learning.