Process Engineer

Location:
Greater Kansas City Area – 100% onsite

Duration: 6 Months (Potential for extensions)

Job Description

The client is looking for a Process Engineer with 3-7 years of experience to support operation, control, and optimization of manufacturing assets and technical processes for a monoclonal antibody (mAb) manufacturing facility. The position focuses on process and equipment, and includes development, data analysis, troubleshooting, technology transfer, and continuous improvement activities. The process engineer plays a key role in day‑to‑day operations as well as in local and major capital project equipment design, installation, commissioning, qualification, and validation.

This person will focus on execution on the floor, commissioning, SIP/CIP controls, P&IDs, PFDs, and related activities.

• Provide technical support and engineering solutions for process and equipment‑related issues, including delivery of local and major capital projects.
• Provide on‑floor support to the manufacturing teams regarding equipment and process troubleshooting.
• Ensure issues are identified and captured in the relevant QMS, and perform root cause analysis with appropriate CAPAs.
• Ensure equipment and processes operate in an expected state of control, aligned with regulatory commitments, GMPs, and client standards.
• Ensure changes, maintenance, and other interventions do not impact the qualified state of the equipment, and provide maintenance oversight for process equipment.
• Ensure any changes are documented appropriately through the change‑management system.
• Use data‑driven analysis of process and equipment to understand performance and capacity, identify, recommend, and implement improvements to optimize system performance.
• Participate in design, development, execution, commissioning, qualification, and validation activities for major projects.
• Exemplify a “Safety First and Quality Always” mindset; collaborate to identify potential risks, sources of variability, improvements, and value engineering opportunities to maximize project return and technical success.
• Create, review, and revise relevant documentation including user requirement specifications, P&IDs, PFDs, safety and environmental assessments, commissioning and qualification documents.
• Manage quality events as assigned – Deviation, Change Control, CAPA.
• Prepare change‑management plans and complete corresponding action items.
• Understand the basis for qualification of equipment and ensure equipment/systems are appropriate for intended purpose.

• Bachelor’s degree in a science or engineering discipline.
• 3–7+ years of experience in medical device, pharma, biotechnology, or other regulated industry.
• Working knowledge of cGMP standards and/or experience working in a regulated environment.
• Demonstrated success operating in cross‑functional teams.
• Self‑motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.

• Experience in capital project design, development, and execution.
• Understanding of monoclonal antibody / recombinant protein manufacturing processes.
• Experience with SAP, ERP, AutoCAD, Veeva Vault.
• Understanding and application of RCI, FMEA, and QRM tools.
• Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.