5656 Utility Engineer
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 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 gas/chemical systems.
Support the Company’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 on assignment.
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, 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 necessary.
Support Global Engineering on major projects in a user team role.
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 technicians.
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 for SE05.
8-11 years of work experience in a GMP manufacturing environment for SE06.
Strong understanding and demonstrated ability with engineering principles and techniques.
Knowledge of FDA and EMA, cGMPs, applicable building codes, and related regulations.
Proficiency in ISA standards and practices for instrumentation.
Knowledge of calibration theories, techniques, and practices.
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.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.