Senior Process Engineer, Biopharma Manufacturing Startup

kyowakirinusa90; Sanford (NC); On-site; USD 120,000 - 170,000; Full time

Job summary

Kyowa Kirin is seeking a Senior Process Engineer to lead the design, commissioning, and operation of the KKNA Manufacturing Facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. You will help startup the new state-of-the-art facility, delivering compliant equipment and systems to drive site objectives and align to global standards.

As an individual contributor, you will collaborate with others to create a supportive environment, act with initiative,

Qualifications

• 5+ years' experience as a process engineer in Pharma, Biopharma, or Life Science manufacturing.
• Knowledge and experience with Single Use Technology (SUT), preferably in monoclonal antibody (mAb) processing; GMP/compliance experience.

Responsibilities

• Provide hands-on support for installation, maintenance, troubleshooting, and repair of assets and systems at the manufacturing facility.
• Own system ownership within Downstream Processing, cradle-to-grave from design to operations acceptance.
• Draft, review, and approve documentation including SOPs, maintenance plans, drawings, and equipment specs.
• Participate in Operational Readiness (OR) planning and execution.
• Collaborate with Manufacturing, Manufacturing Sciences, and Automation on new product introductions.
• Support maintenance, calibration, and qualification plans.
• Manage technical and engineering changes through change control processes.
• Support operations with process fit assessments, root cause analysis, and improvements implementation.
• Drive continuous improvement of drug substance manufacturing processes via technological innovation.
• Support inspections and audits by U.S. and other regulatory agencies.
• Ensure compliance with regulatory requirements, EHS, and GxP expectations.

Skills

MS Office Suite

Education

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

Job description

Kyowa Kirin is seeking a Senior Process Engineer to lead the design, commissioning, and operation of the KKNA Manufacturing Facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. You will help startup the new state-of-the-art facility, delivering compliant equipment and systems to drive site objectives and align to global standards.

As an individual contributor, you will collaborate with others to create a supportive environment, act with initiative,