Director of Engineering and Facilities

The Director of Engineering and Facilities is a leadership position in UI Pharmaceuticals, a Contract Development and Manufacturing Organization (CDMO) located in the College of Pharmacy. This position is responsible for leading people and projects. The department employs process engineers and maintenance staff who are responsible for equipment and facility readiness in a GMP environment. The director is responsible for leading projects with significant departmental scope that have long term-financial, operational, and physical implications for the organization. As a people manager, this position hires, develops, evaluates, and implements personnel actions. Additionally, the director collaborates with Facilities Management, Manufacturing Operations, and Quality Control staff to support facility improvements, control systems and ongoing operations. Financial responsibilities include the development of a departmental budget, project cost projections and initiatives to reduce expenditures while maintaining systems and facility compliance.

This is a highly regulated work environment and may require special gowning procedures and wearing of protective clothing over the head, face, hands, feet, and body and/or donning of other personal protective equipment to meet safety requirements.

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.

We are expanding our capabilities while maintaining our culture focused on quality, customer service and community. Consider accelerating your leadership and technical skills by joining us on the next phase of our growth strategy.

Key Areas of Responsibility

Compliance

• Implement new policies and revise existing programs to ensure compliance with regulatory requirements and cGMP.
• Evaluate completed work to determine whether it meets specifications, standards, and regulations. Direct and implement modifications to bring project, facility, and processes into compliance.
• Oversee equipment listing and coordinate facility and control systems calibrations and associated PMs to keep facility GMP compliant.

Manufacturing

• Lead start-up of sterile facility and process qualification of new manufacturing lines.
• Develop life cycle plans for all manufacturing equipment.
• Recommend design improvements to optimize manufacturing and safety procedures in accordance with divisional goals.

Leadership

• Instill a safe and compliant work environment.
• Hire, develop and manage the performance of staff.
• Interpret and implement HR policies and procedures and assure staff are compliant with university policies and procedures.

Training/Education

• Collaborate with Quality Assurance and Manufacturing Operations on the design, evaluation, and coordination of employee training on new equipment and processes.
• Be a Subject Matter Expert (SME) to other departments on the operation of equipment and facilities.

Financial

• Develop departmental budget by recommending capital equipment, spare parts and service agreements for equipment and facilities.
• Provide oversight and control of departmental operating budget and project expenditures.
• Set financial priorities for projects and project budgets.

Apply Process Improvement, Quality Engineering, and Management Engineering Concepts and Methodologies

• Maintain the engineering change control process and equipment assessments.
• Hands on process improvement and validation for pharmaceutical process equipment.
• Validate life cycle of equipment including authoring of validation master plans, URSs, FAT, SAT, IQ, OQ, PQ and engineering studies.

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

Education Requirement

• M.S. in Engineering (preferably Chemical or Mechanical).

Experience Required

• Minimum 5-7 years of related experience in a pharmaceutical, GMP environment, laboratory, or biological environment. This experience is evidenced by demonstration of knowledge and/or skills in areas such as: isolator operation, automated technologies, environmental controls, utilities (WFI and clean steam) aseptic processes.
• Experience or knowledge in quality control.
• Experience in qualifying facility, equipment, and control systems.
• Demonstrated ability to communicate effectively, orally and in technical writing, to a variety of constituents internal and external to the organization.
• Strong skills in developing SOPs, work instructions, validation documents, deviations, investigations, and batch records.
• Knowledge of pharmaceutical regulations, FDA, cGMP, EU, ISPE, etc.
• Intermediate skills creating and editing documents in MS Excel and Word or comparable programs.
• Professional experience working effectively with individuals from a variety of backgrounds and perspectives.

Desirable Qualifications

• Pharmaceutical, Manufacturing, or Engineering project-related experiences including lyophilizer operation and/or maintenance.
• Experience with Process Mapping and/or project management.
• Understanding of Six Sigma and Lean manufacturing methodology.
• Experience operating under design control and GMP manufacturing.
• Experience with SCADA systems, Metasys systems, or JCI controls in heavy industries and pharmaceuticals.
• Microbiology and environmental monitoring experience.

Benefits Highlights

• Regular salaried position. 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.
• For more information about Why Iowa? Click here.

The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, or associational preferences.