Senior Biopharma Process Engineer: Tech Transfer & GMP

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

Well-Being and Work/Life Programs

Long-Term Incentive Program

Life & Disability Insurance

Pet Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin North America seeks a Senior Process Engineer to design, commission, and operate the new manufacturing facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. You will deliver reliable, compliant equipment and systems aligned with regional and global standards.

As an individual contributor, you will collaborate across Manufacturing, Quality, and Engineering, maintain cradle-to-grave accountability for downstream processing, and drive

Qualifications

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

Responsibilities

• Provide hands-on support and guidance for 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.

Skills

Interpersonal skills

Communication

Decision making

Education

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

Tools

MS Office Suite

Job description

Kyowa Kirin North America seeks a Senior Process Engineer to design, commission, and operate the new manufacturing facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. You will deliver reliable, compliant equipment and systems aligned with regional and global standards.

As an individual contributor, you will collaborate across Manufacturing, Quality, and Engineering, maintain cradle-to-grave accountability for downstream processing, and drive