Senior Process Engineer, Biopharma Process Tech Transfer
NCBioImpact
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Job summary
Kyowa Kirin North America is seeking a Senior Process Engineer to design, commission, and operate the KKNA Manufacturing Facility. This role covers Tech Transfer, process definition, troubleshooting, and optimization as we startup a state‑of‑the‑art site.
You will collaborate across teams with a patient‑centered focus and drive for reliable, compliant equipment and systems. You will lead documentation, support regulatory readiness, and contribute to continuous improvement of drug substance
Qualifications
- Minimum 5 years’ experience as a process engineer in Pharma/Biopharma/Life Science manufacturing.
- Knowledge of GMP and quality compliance for clinical and commercial manufacturing.
- Experience 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 at the manufacturing facility.
- Own downstream processing systems from design through operations acceptance.
- Draft, review and approve operating procedures, maintenance plans, and equipment specs.
Skills
Education
Tools
Job description
Kyowa Kirin North America is seeking a Senior Process Engineer to design, commission, and operate the KKNA Manufacturing Facility. This role covers Tech Transfer, process definition, troubleshooting, and optimization as we startup a state‑of‑the‑art site.
You will collaborate across teams with a patient‑centered focus and drive for reliable, compliant equipment and systems. You will lead documentation, support regulatory readiness, and contribute to continuous improvement of drug substance
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