The Associate Process Engineer works with engineering, facilities, manufacturing operations, and quality control staff to support University of Iowa Pharmaceuticals (UIP) facility and its ongoing operations. Responsibilities include supporting the day-to-day manufacturing activities to optimize processes and resolve equipment issues across sterile and non-sterile production units. Major areas of focus include authoring and executing equipment and process qualifications; and operating and troubleshooting control systems (SCADA, Metasys, etc.); supporting and preforming equipment calibration and preventive maintenance (PM) programs.

About the University of Iowa Pharmaceuticals

UI Pharmaceuticals (UIP) is an FDA-registered pharmaceutical manufacturing facility within the University of Iowa College of Pharmacy. With more than 50 years of expertise in contract pharmaceutical manufacturing and testing, UIP plays a vital role in advancing life saving medications from early development through clinical trials and into commercial markets. As part of a major academic medical center, UI Pharmaceuticals combines scientific innovation with a commitment to quality and patient impact. Its mission-driven work supports partners across the globe in delivering safe, effective therapies to those who need them most.

Key Areas of Responsibility

Analysis

• Support Engineering and Manufacturing teams across multiple manufacturing lines.
• Perform root cause analysis and troubleshoot facilities, manufacturing process and equipment issues in collaboration with Engineering, Facilities, and Manufacturing.
• Review and redline of Piping and Instrument Diagram during service, validation, and preventive maintenance, and ensuing all changes are documented in accordance with current Good Manufacturing Practices (cGMP).
• Collaborative with the Engineering and Production teams and vendors to coordinate required services and identify critical supplier-based replacement parts.

Engineering Project Management

• Manage department level projects with potential organization-wide impact.
• Maintain the engineering change control process and perform equipment assessments.
• Perform hands-on process improvement and validation for pharmaceutical process equipment.
• Support equipment lifecycle validation by authoring or reviewing validation master plans, User Requirement Specifications (URSs), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and engineering studies.

Compliance

• Review and evaluate completed work to ensure it meets all applicable specifications and regulatory requirements.
• Initiate, implement, or review new policies and programs to ensure compliance with Food and Drug Administration (FDA) requirements to ensure and current Good Manufacturing Practices (cGMP).
• Collaborate with Engineering and Quality Assurance to develop and deliver GMP, process, equipment training for new and existing facilities.
• Initiate, develop, and implement process improvement projects to achieve regulatory compliance, reduce 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.
• Coordinate with Engineering and Facilities to review preventive maintenance (PM) programs and implementation plans, manage PM schedules and communicate timelines with Quality Assurance and Production teams to minimize impact on manufacturing.
• Manage equipment lists and calibration schedules.

Application of Technical Knowledge

• Determine root causes of basis problems; develop recommendations for corrective actions, and follow-up to ensure completion.
• Manage validation for off-the-shelf equipment including authoring and executing SAT, IQ, OQ protocols.
• Serve as Subject Matter Expert (SME) for Supervisory Control and Data Acquisition (SCADA), Johnson Controls and Metasys control systems; oversee change control and lead validation activities, as needed.
• Serve as SME to train staff on equipment operation and production line processes.

Financial

• Manage project and departmental budgets and assist in developing budget estimates.

Leadership

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

To obtain the full job description including key areas of responsibility, technical competencies, and desirable qualifications, please contact Libby Kleppe at libby-kleppe@uiowa.edu.

Education Requirement

• Bachelor’s degree in engineering.

Experience Required

• Minimum three (3) years post-degree engineering experience in a manufacturing environment, including:
  • Experience with Programmable Logic Controllers (PLCs).
  • Process mapping and/or project management.
  • Equipment preventive maintenance (PM), sensor calibration, troubleshooting in a manufacturing setting.
• Ability to read and interpret automated control system Piping and Instrument Diagram (P&ID).
• Demonstrated ability to communicate effectively, both verbally and in writing, with a wide variety of internal and external stakeholders, including strong technical writing skills.
• Experience developing and maintaining technical documentation, including Standard Operating Procedures (SOPs), validation documents, deviations, investigations, change controls, and CAPA’s.
• Ability to work effectively on multi-disciplinary teams with individuals from a variety of backgrounds and perspectives.

Desirable Qualifications

• Knowledge of qualification and operation of automated enclosures, isolators, or laboratory equipment.
• Experience supporting pharmaceutical manufacturing or quality related projects.
• Knowledge of pharmaceutical regulations and industry standards, such as Food and Drug Administration (FDA), current Good Manufacturing Practice (cGMP), European Union (EU), International Society for Pharmaceutical Engineering (ISPE) guidelines.
• Experience with Rockwell Automation Studio 5000.
• Experience with Supervisory Control and Data Acquisition (SCADA) systems, Human Machine Interfaces (HMI), environmental monitoring and control systems, and Variable Frequency Drives (VFD).

Application and Position Details

• In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:
  • Resume
  • Cover Letter
• Job openings are posted for a minimum of 14 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. 5 professional references will be requested at a later step in the recruitment process. For additional questions, please contact Libby Kleppe at libby-kleppe@uiowa.edu.
  

Benefits Highlights

• Regular salaried position. Pay level 4B Located in Iowa City, Iowa.
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans.
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