GMP Process Engineer

University of California, Irvine • Irvine, CA

2d

About The Position

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.

Requirements

• 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
• Must be able to provide proof of work authorization

Nice To Haves

• 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

Responsibilities

• 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
• manage and ensure safe and on-time completion of routine equipment, systems, and instrument calibrations per applicable specifications

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level