Process Engineer

Position: Process Engineer

Location: Greater Kansas City Area

Job Description:

The client is looking for a Process Engineer with 3-7 years of experience responsible for supporting the operation, control and optimization of manufacturing assets and technical processes for a monoclonal antibody (mAb) manufacturing facility. The position will focus on process / equipment and is engaged in 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 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, etc.

Responsibilities:

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 quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned..

Ensure equipment and processes are operating in an expected state of control, and in alignment with regulatory commitments, GMPs and all relevant 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 and identify, recommend, and implement improvements to optimize system performance. Participate in design, development, execution, commissioning, qualification, and validation activities for major projects.

Exemplify “Safety First and Quality Always” mind-set. Collaborate with team members to identify potential risks, sources of variability, improvement, 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 etc.

Prepare change management plans and complete corresponding action items. Understand the basis for the qualification of equipment and ensure that the equipment / systems are appropriate for the intended purpose.

Requirements:

Education: Bachelor’s degree in a science or engineering discipline.

Experience: 3-7+ years’ 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.

Nice to Have:

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.