Full Job Description
Your day-to-day will include:
• Responsible for supporting the operation, control, and optimization of manufacturing assets and technical processes at the Elwood, Kansas monoclonal antibody (mAb) facility.
• Serve as a subject matter expert in both process and equipment performance, contributing to development, data analysis, troubleshooting, technology transfer, and continuous improvement initiatives.
• Play a key part in day-to-day manufacturing operations while also supporting local and large-scale capital projects, including equipment design, installation, commissioning, qualification, and validation-helping drive the future of biologics manufacturing at the site.
• Process & Equipment Support: Provide technical expertise and engineering solutions for process and equipment-related challenges.
• Support manufacturing operations on the floor by troubleshooting issues and ensuring reliable performance.
• Operational Excellence & Compliance: Ensure processes and equipment operate in a controlled, compliant state aligned with cGMP standards and regulatory expectations.
• Support investigations, root cause analysis, and implementation of CAPA.
• Data Analysis & Continuous Improvement: Utilize data-driven insights to monitor performance, identify variability, and implement improvements that enhance efficiency, throughput, and process robustness.
• Project Engineering & Capital Execution: Support the full lifecycle of capital projects, including design, installation, commissioning, qualification, and validation of equipment and systems.
• Change Management & Documentation: Ensure all changes to processes and equipment are properly assessed, documented, and executed through change control systems.
• Maintain and review technical documentation such as process flows, specifications, and validation protocols.
• Cross-Functional Collaboration: Partner with Manufacturing, Quality, Engineering, and other teams to resolve technical challenges, mitigate risks, and drive successful project outcomes.
You have the following technical skills and qualifications:
• Requirement - Bachelor's degree in Life Sciences, Electrical Engineering, Industrial Engineering, Mechanical Engineering, a related field, or a foreign equivalent plus 3 years progressively responsible post-baccalaureate experience in job offered or any engineering related roles.
• Relevant experience - Applicants must have 3 years of experience in the following: (1) Working in pharmaceutical, biotechnology, or a related industry; (2) cGMP standards and experience working in a regulated environment; (3) aseptic processing techniques and cleaning/sanitization methodologies; (4) Process Validation, completing risk assessments (FMEA), and Process Performance Qualifications (PPQ); (5) interpreting and complying with USDA/FDA/EMA regulations; (6) utilizing statistical tools to analyze process trends, identify deviations, and determine corrective actions (CAPA); and (7) operating and maintaining Single-Use Bioreactor Systems, SCADA, and MES (Manufacturing Execution Systems).
