Senior Process Engineer - Biopharma Manufacturing & Startup

Kyowa Kirin North America; Sanford (NC); On-site; USD 130,000 - 145,000; Full time

Benefits offered by this job

401K with company matching

Annual Bonus Program (Sales Bonus for

Generous PTO and Holiday Schedule

Healthcare Benefits (Medical, Dental,

HSA & FSA Programs

Well-Being and Work/Life Programs

Long-Term Incentive Program (subject"}

Life & Disability Insurance

Concierge Service

Pet Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin North America is seeking a Senior Process Engineer to design, commission, and operate a new state-of-the-art manufacturing facility in Sanford, NC. You will contribute to tech transfer, process definition, troubleshooting, and optimization, while upholding GMP, quality, and regulatory standards.

As an individual contributor, you’ll collaborate across Manufacturing, Mfg Sciences, and Automation to deliver reliable, compliant equipment and processes.

Qualifications

• 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.

Responsibilities

• Provide hands‑on support for installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility.
• Own system ownership within Downstream Processing from cradle‑to‑grave design through operations acceptance.
• Draft, review, and approve documentation including operating procedures, maintenance plans, engineering drawings, and equipment specifications.
• Participate in Operational Readiness 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.

Skills

SUT knowledge

GMP knowledge

Root cause analysis

Troubleshooting

Process optimization

Documentation

Change control processes

Cross-functional collaboration

Communication skills

Project management

Education

Bachelor's degree in Chemical, Mechanical, Biotechnology Engineering, or related field

Tools

MS Office Suite

Job description

Kyowa Kirin North America is seeking a Senior Process Engineer to design, commission, and operate a new state-of-the-art manufacturing facility in Sanford, NC. You will contribute to tech transfer, process definition, troubleshooting, and optimization, while upholding GMP, quality, and regulatory standards.

As an individual contributor, you’ll collaborate across Manufacturing, Mfg Sciences, and Automation to deliver reliable, compliant equipment and processes.