Process Engineer, Biologics Manufacturing

Elanco; Elwood (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Elanco is seeking a manufacturing engineer to support and optimize operations at the Elwood (KS) monoclonal antibody facility. You will act as a technical expert for process and equipment, contribute to development, data analysis, and technology transfer, and participate in capital projects from design through validation.

The role requires a life sciences or engineering degree with 3+ years in pharma/biotech, cGMP knowledge, aseptic processing, and experience with validation, CAPA, and

Qualifications

• Bachelor's degree required in a life sciences or engineering field with 3+ years in related roles.
• Experience in pharma/biotech with regulatory environment exposure.
• Familiarity with cGMP, aseptic processing, and validation activities.

Responsibilities

• Support operation, control, and optimization of manufacturing assets and processes at the Elwood facility.
• Serve as SME for process and equipment performance; aid development, data analysis, troubleshooting, tech transfer, and improvements.
• Contribute to capital projects with equipment design, installation, commissioning, qualification, and validation.
• Provide technical solutions for process/equipment challenges and troubleshoot manufacturing on the floor.
• Ensure processes/equipment operate in a compliant, validated state per cGMP and regulatory expectations.
• Assist investigations, root-cause analysis, and CAPA implementation.
• Use data analytics to monitor performance, identify variability, and drive improvements.
• Support full lifecycle of capital projects from design to validation of equipment and systems.
• Document changes through change control; maintain process flows and validation protocols.
• Collaborate cross-functionally with Manufacturing, Quality, and Engineering to resolve issues.

Skills

Pharma industry

cGMP knowledge

Aseptic processing

Process Validation

FMEA risk assessment

PPQ

Regulatory compliance

Statistical tools

Bioreactor SCADA MES

Education

Bachelor’s degree in Life Sciences, Electrical Engineering, Industrial Engineering, Mechanical Engineering, or related field

Job description

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.