UCI Health · 19 hours ago
GMP Process Engineer
Irvine, CA
Full-time
Onsite
Mid Level
3+ years expUCI Health is a leading academic institution known for its research and innovation. The GMP Process Engineer will support the GMP Facility in the School of Medicine, overseeing maintenance and reliability of engineering activities involved in the design, maintenance, and repair of utilities systems and production equipment.
Health CareHospitalMedical
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
Qualification
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
Benefits
Medical insurance
Sick and vacation time
Retirement savings plans
Access to a number of discounts and perks
Company
UCI Health
UCI Health offers acute and general care services specializing in treating urology, gynecology, kidney disorders, and cancer programs.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Manlin Kitty Huang Lin, MS, CPA
Director of Finance/ CFO
Nate Shinagawa MHA, FACHE
Chief Operating Officer and Senior Vice President
Recent News
Precedence Research
2025-11-27
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