Company: Aequor Technologies
Posted on: May 26, 2023
This position reports to the Sr. Manager of Frontline Engineering
in the Facilities and Engineering Department. The Utility Engineer
is a subject matter expert in plant utilities (WFI, WRO, clean
steam, compressed air, and plant steam) and supports manufacturing
and utility operations at the Vacaville site.
- Identify, analyze, and design improvements and capabilities for
facility, utility, process, and equipment systems.
- Understand and provide technical support for all site utility
systems including natural gas systems, water pretreatment systems,
drain systems, water for injection systems, plant & clean steam
systems, cooling water systems, lab vacuum, air systems, and bulk
- Support Roche/Genentech's Right to Operate and to Make, Assess,
and Release our pharmaceuticals; ensuring our patients are able to
receive an uninterrupted quality supply of their necessary
prescriptions on time
- Develop and maintain engineering documentation such as PFDs,
P&IDs, design drawings and specifications, design review, and
protocols (FAT, SAT, and IQ).
- Support development and review of project documentation such as
schedules, budget, URS, PEP, RFQs, Contractor Bid Packages,
Statements of Work, and Credit Applications.
- Drive and manage the planning and design phases including
project initiation and conceptual/basic/detailed design depending
- Daily process monitoring and analysis of manufacturing data,
engineering evaluation and support for discrepancy investigations,
and identification/implementation of immediate corrective or
preventative actions to ensure continued compliant operation
- Support debug, operational and performance qualification, and
handover to operations.
- Manage construction phases including contractors, construction
supervision, Genentech business processes, change orders,
punch-list, turnover, and closure.
- Immediate resolution of emergent issues; including
troubleshooting process, equipment, and system malfunctions or
failures on a 24/7 basis, including weekends and holidays as
- Support Global Engineering on major projects in a user team
- Collaborate with peers in continuous improvement of technical
infrastructure including standards, practices, specifications,
procedures, and business processes.
- Support and/or lead identification and implementation of near
and long term changes including; analyzing and solving process
performance problems, root cause analysis, and
ownership/sponsorship of corrective and preventative actions
- Provide technical guidance to utility operations
Leadership & People Management:
- Individual Contributor
BS Engineering degree from an accredited university. Electrical,
mechanical, or chemical engineering is preferred.
- 5-7 years of work experience in a GMP manufacturing environment
- 8-11 years of work experience in a GMP manufacturing
environment for SE06
- S trong understanding and demonstrated ability with engineering
principles and techniques.
- Knowledge of FDA and EMA, cGMPs, applicable building codes, and
- Proficiency in ISA standards and practices for
- Knowledge of calibration theories, techniques, and
- Knowledge of project lifecycle including initiation, design,
construction, and commissioning/validation.
- Effective communication and interpersonal skills with
technical, operations, maintenance, quality, and senior management
personnel . Work Environment/Physical Demands/Safety Considerations
- Work environment includes office, utility, clean room,
warehouse, laboratory, roof, and outdoors.
- Physical demands require sitting, standing, walking, climbing
stairs, ladders, scaffolding, and cleanroom gowning.
Job descriptions are not intended, and should not be construed, to
be all-inclusive lists of all responsibilities, skills, efforts, or
working conditions associated with a job. While this description is
intended to be an accurate reflection of the job requirements,
management reserves the right to modify, add, or remove duties and
to assign other duties as necessary.
Keywords: Aequor Technologies, Vacaville , Engineer III, Engineering , Vacaville, California
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