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 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…