Senior Process Engineer-Upstream
1 week ago
The Senior Process Engineer is responsible for the design, commissioning, and operation of the KKNA Manufacturing Facility, including Tech Transfer, Process Definition, Troubleshooting, and Process Optimization. This role requires collaboration with the team, demonstrating compassion and integrity in all work, and utilizing ability to facilitate alignment among diverse viewpoints to make informed decisions and drive consensus.
Key Responsibilities:
- Provide hands-on support and guidance of installation, maintenance, troubleshooting, and repair of assets and systems supporting the manufacturing facility.
- Take system ownership within Upstream Processing, Downstream Processing, or Solution Preparations and maintain a 'cradle-to-grave' accountability for the systems assigned, from design through operations acceptance.
- Create, review, and approve documentation such as operational procedures, maintenance plans, engineering drawings, and equipment specifications.
- Participate in the facility's Operational Readiness (OR) planning and execution.
- Collaborate with manufacturing, manufacturing sciences, and automation to evaluate new product introductions.
- Assist with preparation of maintenance, calibration, and qualification plans.
- Manage technical and engineering changes (change control).
- Support internal and external audits.
Requirements:
Bachelor's degree qualified in Chemical, Mechanical, or biotechnology engineering or 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), 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.
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