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 follow-through. Ability to work and adapt through change, execute work independently with flexibility, and manage ambiguity in a dynamic, fast-paced, high-growth environment. Commitment to continuous learning and development. Cultural sensitivity and the ability to build consensus within a multinational organization.

Physical Demands:

• This role will initially work on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.
• Work is 100% on-site. This is not a hybrid or remote role.

Working Conditions:

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $130,000 to $145,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

401K with company matching

Annual Bonus Program (Sales Bonus for Sales Jobs)

Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days

Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)

HSA & FSA Programs

Well-Being and Work/Life Programs

Long-Term Incentive Program (subject to job level and performance)

Life & Disability Insurance

Concierge Service

Pet Insurance

Tuition Assistance

Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected] . Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tes