Senior Process Engineer

The role

The Senior Process Engineer is responsible for the design, commissioning, and operation of the KKNA Manufacturing Facility. This role involves tech transfer, process definition, troubleshooting, and process optimization to support the startup of a new facility.

What you will do

• Provide hands-on support for installation, maintenance, troubleshooting, and repair of assets and systems.
• Assume system ownership within Downstream Processing.
• Draft, review, and approve documentation including operating procedures and engineering drawings.
• Participate in Operational Readiness planning and execution.
• Collaborate with Manufacturing, Manufacturing Sciences, and Automation for 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 and root cause analysis.
• Drive continuous improvement of drug substance manufacturing processes.
• Support inspections and audits conducted by regulatory agencies.

Required qualifications

• Bachelor’s degree in Chemical, Mechanical, Biotechnology Engineering, or a related field.
• 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).
• Knowledge and understanding of Good Manufacturing Practices (GMP) and quality compliance issues.
• Proficient in MS Office Suite.
• 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.
• Ability to work and adapt through change and execute work independently.
• Cultural sensitivity and ability to build consensus within a multinational organization.

Nice to have

• Single Use Technology (SUT) preferably in monoclonal antibody (mAb) processing.
• Experience with starting up and operating a biopharma manufacturing facility.

Benefits

• 401K with company matching
• Annual Bonus Program
• Generous PTO and Holiday Schedule including 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
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

About the company

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation. The company works across the continuum from drug discovery to commercialization.