Senior Process Engineer, Manufacturing – mAb Ops & CQV

elanco; Elwood (KS); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

relocation packages

8-week parental leave

9 Employee Resource Groups

Annual bonus opportunity

Job summary

Elanco’s Elwood, Kansas facility is seeking a Sr. Process Engineer to design, operate, and optimize manufacturing processes for monoclonal antibodies.

You’ll serve as a SME for processes and equipment, driving data analysis, technology transfers, and continuous improvement to support both daily operations and capital projects. The role requires a Bachelor's degree in science or engineering and 10 years in a regulated pharma/biotech setting.

Qualifications

• Education: Bachelor's degree in a science or engineering discipline.
• Experience: 10 years of experience in the pharmaceutical, biotechnology, or a related regulated industry.
• Top 2 skills: Strong analytical thinking and technical problem-solving skills; ability to prioritize and deliver results in cross-functional teams with minimal supervision.

Responsibilities

• Provide engineering solutions for process and equipment issues, enabling on-floor support for root cause analysis and CAPA implementation.
• Ensure equipment and processes operate in a state of control per regulatory commitments, cGMPs, and Elanco standards.
• Use performance and capacity analysis to identify and implement improvements that optimize system performance.
• Support project teams in local and major capital projects, participating in design, development, commissioning, qualification, and validation (CQV).
• Create, review, and revise critical technical documentation including URS, P&IDs, PFDs, and safety/environmental assessments.
• Participate in hazardous operations and process safety reviews to identify and mitigate risks.
• Partner with cross-functional teams to identify risks, variability sources, and value engineering opportunities.
• Prepare and execute change management plans and action items for process interventions.

Skills

Analytical thinking

Technical problem-solving

Cross-functional teamwork

Minimal supervision

Education

Bachelor's degree in science/engineering

Tools

SAP

AutoCAD

Veeva Vault

RCI

FMEA

QRM tools

Job description

Elanco’s Elwood, Kansas facility is seeking a Sr. Process Engineer to design, operate, and optimize manufacturing processes for monoclonal antibodies.

You’ll serve as a SME for processes and equipment, driving data analysis, technology transfers, and continuous improvement to support both daily operations and capital projects. The role requires a Bachelor's degree in science or engineering and 10 years in a regulated pharma/biotech setting.