Process Engineer, Biologics Manufacturing

Kansas Ag Connection; Kansas; Sur place; USD 85 000 - 125 000; Plein temps

Résumé du poste

Elanco is seeking a Process Engineer for Biologics Manufacturing in Kansas. The role focuses on supporting operation, control, and optimization of monoclonal antibody manufacturing assets at the Elwood site, with emphasis on process and equipment performance and continuous improvement.

You will drive development, data analysis, troubleshooting, technology transfer, and CAPA implementation, ensuring regulatory compliance and alignment with cGMP standards.

Qualifications

• Bachelor's degree in life sciences or engineering with 3 years related experience.
• Experience in pharmaceutical/biotech regulatory environments (cGMP).
• Experience with Process Validation, PPQ, and FMEA risk assessments.

Responsabilités

• Support operation, control, and optimization of manufacturing assets.
• Serve as SME for process and equipment performance; support development and tech transfer.
• Support capital projects including design, installation, qualification, and validation of equipment and systems.
• Ensure processes and equipment operate in a cGMP-compliant state and through change control systems.
• Perform data-driven insights to monitor performance and improve efficiency and throughput.
• Collaborate with Manufacturing, Quality, and Engineering to resolve technical challenges.

Connaissances

Data analysis

Process optimization

CAPA implementation

Cross-functional collaboration

Formation

Bachelor's degree in Life Sciences / Engineering

Outils

SCADA

MES

Single-Use Bioreactor Systems

Description du poste

# Process Engineer, Biologics ManufacturingBack to search resultsApply to this positionFollow CompanyMore Jobs from ElancoSend to Friend**At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.** **At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.** **Making animals' lives better makes life better - join our team today!** 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). Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.To apply please click on APPLY TO THIS POSITIONApply to this position