Pharmaceutical Associate Process Engineer

This position works with engineering, facilities, sterile production, and quality control staff to support the new University of Iowa Pharmaceuticals (UIP) facility start-up and ongoing operations. This includes the day-to-day operation to optimize processes and solve equipment issues of a sterile process manufacturing unit. Major areas of focus include authoring and execution of process qualification and validation, formulation, and batch record drafting for automated systems.

• Assist with initiation, implementation, and review of new policies and programs that comply with FDA requirements to ensure that cGMP regulations are met.
• Assist with initiation, development, and implementation of process-related projects to achieve regulatory compliance, lower costs, and improve quality.
• Determine basic problem causes; develop recommendations for corrective action, and follow-up to ensure completion of corrective action.

• Support the Engineering and Sterile Manufacturing teams in the start-up of sterile facility and process qualification of new manufacturing lines.
• Review and redline of Piping and Instrument Diagram during service, validation and preventive maintenance, and be able to document changes according to GMP practices.
• Work with engineering and facilities on PMs reviews and implementation plans, manage PMs schedules, and communicate with different areas (quality and sterile production) on PMs schedules and time frame for the execution of PM without impact on sterile manufacturing. Manage equipment list and calibration schedule.
• Collaboratively work with engineering and sterile production in required services and replacement parts with supplier based on criticality.

• Be a change agent and team player, passionate to improve on current process and be part of the solution.
• Display innovation and creativity in recommendations for improved SOPs, Batch records, IQ, OQ workflow or templates.

• Design, evaluate, and coordinate training of employees on new equipment and processes.
• Will work with Engineering and Quality to perform GMP training, processes and other training for the new facility.

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

• Maintain the engineering change control process and equipment assessments.
• Validate life cycle of equipment including authoring of validation master plans, URSs, FAT, SAT, IQ, OQ, PQ and engineering studies.
• Owner of the Data Trending of Filling parameters, Environmental Monitoring and clean rooms.
• Sample collection when needed and as needed for the WFI system, Clean Steam and other sampling requirements.
• Write SOP's for UIP aseptic processing equipment from OEM manuals including vial washer, Depyrogentation tunnels, filler/stopper, Lyophilizers, autoclave, vial capper, and external vial washer.

For a full job description, please send an e-mail to the contact listed below.

Education Requirement

• B.S. in Engineering or similar fields such as Biology, Chemistry, or Microbiology with experience or knowledge in quality control.

• Minimum two 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.
• Demonstrated ability to communicate effectively, orally and in writing including technical writing skills, to a variety of constituents internal and external to the organization.
• Strong writing skills in SOPs, validation documents, deviations, investigations and batch records.
• Knowledge of pharmaceutical regulations, FDA, cGMP, EU ISPE, etc.
• Knowledge in qualification and operation of automated enclosures, isolators or laboratory equipment.
• 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.
• A valid driver's license, plus the ability to meet and maintain compliance with the University Driving Policy.

• Pharmaceutical, Manufacturing, Engineering, Quality project related experiences.
• Sterile facility start-up experience including validation cycles and cleaning validation of systems.
• Experience with Process Mapping and/or project management.
• Understanding of Six Sigma and Lean manufacturing (6S) methodology.
• Experience operating under design control and GMP manufacturing.
• Experience with SCADA systems, Metasys systems, or JCI controls in heavy industries and pharmaceutical.
• Microbiology and environmental monitoring experience.
• Intermediate skills creating and editing documents or projects in MS Visio, PowerPoint, and Project or comparable software.

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, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.