Associate Process Engineer

The Associate Process Engineer works with engineering, facilities, manufacturing operations, and quality control staff to support University of Iowa Pharmaceuticals (UIP) facility and ongoing operations. This includes the day-to-day operation to optimize processes and solve equipment issues of sterile and non-sterile process manufacturing units. Major areas of focus include authoring and execution of equipment and process qualification, and operation of control systems (SCADA, Metasys, etc.).  

About the University of Iowa Pharmaceuticals

UI Pharmaceuticals is a Contract Development and Manufacturing Organization (CDMO) within the College of Pharmacy at the University of Iowa. Our mission is to improve quality of life by applying our pharmaceutical expertise to advance innovative products into clinical trials. Our vision is to be the premier partner for biotech, government, and research institutions.  

We are located on the main campus in Iowa City, which offers a great place to live, top rated schools, a vibrant night life, and world class health care facilities. As a University of Iowa employee, you will have access to an excellent benefits package.

Key Areas of Responsibility  

Analysis 

• Support the Engineering and Manufacturing teams on multiple manufacturing lines. 
• Support Engineering, Facilities and Manufacturing by performing root cause analysis and troubleshoot facilities, manufacturing process and equipment problems.  
• Review and redline of Piping and Instrument Diagram during service, validation, and preventive maintenance, and be able to document changes according to current Good Manufacturing Practices (cGMP).  
• Collaboratively work with the Engineering and Production teams and vendors on required services and critical supplier-based replacement parts. 

Engineering Project Management 

• Responsible for projects at the department level that may have lasting impact at the organizational level.  
• Maintain the engineering change control process and equipment assessments.  
• Hands-on process improvement and validation for pharmaceutical process equipment.  
• Validate the life cycle of equipment including authoring or review of validation master plans, User Requirement Specifications (URSs), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Product Qualification (PQ), and engineering studies.  

Compliance 

• Review and evaluate completed work to determine if it meets all relevant specifications and regulations.  
• Initiate, implement, or review new policies and programs that comply with Food and Drug Administration (FDA) requirements to ensure that current Good Manufacturing Practices (cGMP) regulations are met.  
• Collaborate with Engineering and Quality Assurance to conduct GMP, processes, and other training for the new or current facilities and equipment.  
• Initiate, develop, and implement process-related projects to achieve regulatory compliance, lower costs, and improve quality.   

Planning 

• Plan and develop project scope for locally controlled initiatives. 
• Collaborate with Production and Quality Assurance on cross-functional projects to ensure timely and efficient use of staff and resources. 
• Work with Engineering and Facilities on preventive maintenance (PM) reviews and implementation plans, manage PM schedules and communicate with different areas, i.e. Quality Assurance and Production teams, on PM schedules and time frames for the execution of PM without impact on manufacturing.  
• Manage equipment list and calibration schedule.  

Application of Technical Knowledge 

• Determine basic problem causes; develop recommendations for corrective action, and follow-up to ensure completion of corrective action. 
• Manage initiatives in off the shelf equipment SAT, IQ, OQ authoring and execution.  
• Achieve Subject Matter Expert (SME) status for Supervisory Control and Data Acquisition (SCADA), Johnson Control and Metasys control systems, oversee change control and lead validation activities, when needed, for these systems.     
• Act as subject matter expert to perform training on the equipment and operation of the production lines. 

Financial 

• Assume responsibility for project and departmental budget compliance and assist in creating budget estimates for the same.  

Leadership 

• May provide functional and/or administrative supervision of staff. 
• Provide direction, assignments, feedback, coaching and guidance to coworkers to ensure project outcomes are achieved. 
• Manage the successful completion of local scoped projects within budget, on schedule and in compliance with engineering and regulatory requirements. 
• Design, evaluate, and coordinate training of employees on new equipment and processes. 

For a complete job description, please contact Libby Kleppe at libby-kleppe@uiowa.edu