The manager of Process Engineering 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 manager is also 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, this position 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.
Flexibility to work more than 8 hours/day or 40 hours/workweek is required; and business travel may be required. 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.
Key Areas of Responsibility
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. Recommend modifications to bring project, facility, and processes into compliance.
Manage equipment listing and coordinate facility and control systems calibrations and associated PMs to keep facility GMP compliant.
Maintain a suitable system for archiving all equipment and facilities documentation and equipment.
Initiate CAPA, investigation and deviations and work with engineering, quality, and sterile production to determine root cause using 6 sigma practices.
Review and redline of Piping and Instrument Diagram during service, validation, and preventive maintenance, and be able to document changes according to GMP practices.
Direct and/or coordinate PMs for facilities and control systems, manage PMs schedules, and communicate with different areas (quality and manufacturing operations) on PMs schedules and time frame for the execution of PM without impact on operations.
Collaborate with Manufacturing Operations on troubleshooting equipment and facilities issues. Develop and purchase required services and replacement parts with suppliers based on criticality.
Lead validation activities for control systems (SCADA, Metasys, etc.).
Instill a safe and compliant work environment.
Hire, develop and manage the performance of staff.
Assure staff are compliant with UI policies and procedures.
Interpret and implement HR policies and procedures.
Manage the successful completion of multiple projects.
Resolve complex issues across multiple departments within or outside UI.
Supervisor outside contractor work on facilities and equipment.
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.
Assist in company budget development 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.
Collaborate with Quality Assurance and Manufacturing Operations on drafting SOP's and work instructions for new equipment and facilities.
In collaboration with Quality Assurance maintain a document management system for all equipment records including URS, FAT, SAT, IQ/OQ and PQ.
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.
For a complete job description, please contact Libby Kleppe at firstname.lastname@example.org
B.S. in Engineering with experience or knowledge in quality control.
Minimum 5 years 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 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.
Ability to perform effectively in multi-disciplinary teams in a diverse environment.
Intermediate skills creating and editing documents in MS Excel and Word or comparable programs.
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.
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:
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 email@example.com.
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.
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.
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.