"GMP Process Engineer"

GMP Process Engineer

Req ID: 140400

Location: Irvine, California

Division: School of Medicine

Department: CGMP Facility

Position Type: Full Time

Salary Range Minimum: USD $77,000.00/Yr.

Salary Range Maximum: USD $139,200.00/Yr.

Who We Are

Founded in 1965, UC Irvine is a member of the prestigious Association of American Universities and is ranked among the nation's top 10 public universities by U.S. News & World Report. The campus has produced five Nobel laureates and is known for its academic achievement, premier research, innovation and anteater mascot. Led by Chancellor Howard Gillman, UC Irvine has more than 36,000 students and offers 224 degree programs. It's located in one of the world's safest and most economically vibrant communities and is Orange County's second-largest employer, contributing $7 billion annually to the local economy and $8 billion statewide.

To learn more about UC Irvine, visit www.uci.edu.

The School of Medicine has completed construction and qualified a new GMP Facility for use following Good Manufacturing Practices (GMPs). The facility consists of seven ISO classified cleanrooms and support spaces with supporting utilities and infrastructure for manufacturing purposes, a storage warehouse for raw and finished product, a freezer farm, and an adjacent Quality Control laboratory.

The GMP facility is intended for the manufacturing of pharmaceutical and/or cellular products. Specifically, the collection, processing, storage, and release of cell therapy and related products. The GMP facility will produce product and material suitable for clinical trials of cell therapeutics, including stem cell populations and bone marrow transplantation, as well as Chimeric Antigen Receptor (CAR) T-cells.

Your Role on the Team

The GMP Process Engineer will support the facilities of the GMP Facility in the School of Medicine. The GMP Process Engineer will oversee the maintenance and reliability of engineering activities involving the design, maintenance and repair of utilities systems, facility, production equipment, non-production equipment within the GMP facility. They shall also manage and ensure safe and on-time completion of routine equipment, systems, and instrument calibrations per applicable specifications.

The Process Engineer will report administratively to the GMP Supervisor, Finance & Administration. Oversight and direction will also be provided by the GMP Facility Leadership. This reporting structure is consistent with the expectation that the facility will be used by investigators across the entire biomedical spectrum residing within multiple UCI academic units, will of necessity interface with UCI Health, and will have significant extramural contracted use.

What It Takes to be Successful

Required:

• Working knowledge of engineering principles and methods in order to independently perform professional engineering design work of limited scope and complexity.
• In-depth knowledge of pharmaceutical manufacturing and laboratory unit operations and GMP requirements.
• Knowledge of troubleshooting techniques and methodologies. Demonstrate critical and analytical thinking to discern complex modalities into simple and basic concepts.
• Working knowledge necessary to begin independent application of principles, practices and procedures in the completion of assignments.
• Organizational abilities and decision-making to prioritize multiple work assignments at one time.
• Outstanding written and oral communication skills. Ability to lead discussions, to particulate test procedures, and to make effective presentations. Utilize effective listening and questioning techniques.
• Present information and ideas effectively, formally and informally, verbally and in writing to others in a manner that facilitates understanding.
• Attention to details and high level of accuracy
• Ability to work in a collaborative manner, to assist in identifying any challenges or barriers.
• Ability to adapt to changing priorities.
• Ability to function as a member of a team.
• Adherence to excellent customer service principles.
• Knowledge of personal computer, word processing, data management, and spreadsheet software.
• Knowledge of standard precautions and biosafety. Knowledge of Occupational Safety and Health Act (OSHA) and laboratory safety regulations.
• Practices safety awareness at all times and considers impact of actions prior to executing activities.
• Must be able to write clear technical reports in the scientific format. Must be able to maintain logs and documentation in the same manner.
• Maintains appropriate interdepartmental communication.
• In depth knowledge of Good Laboratory Practices (FDA, CAP, TJC, AABB, CADPH)
• Knowledge of federal and state legislation and regulatory requirements pertaining to the cellular therapy production.
• Bachelor's degree in related area and / or equivalent experience / training
• Minimum 3+ years of experience in an engineering, equipment, utilities technical expertise.
• Experience with equipment, systems and instrument troubleshooting, repair, testing and verification of system integrity

Preferred:

• Experience working in an academic medical setting.
• 2+ year experience working in an academic medical setting (preferred)
• Experience in reviewing GMP/GLP related documents (SOP's, protocols, batch records, technical reports, etc.).
• Working knowledge of the GMP principles with respect to FDA regulations. (e.g. 21 CFR Part 11, 210, and 211 compliance knowledge
• Significant experience supporting and implementing utilities systems, equipment operations, facilities infrastructure