Mentor Technical Group · 18 hours ago
Clean Utilities Engineer
Concord, NC
Full-time
Onsite
Senior Level
7+ years expMentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. The Clean Utilities Engineer will support site GMP Utilities systems and be a key player in the construction and operation of GMP Utilities, ensuring compliance and operational excellence.
BiotechnologyFacility ManagementLife Science
Responsibilities
Support to the site Subject Matter Expert (SME) for site GMP Utilities systems (PW, WFI, Clean Steam, etc.), and the ancillary systems associated within their facilities
Specific responsibility in the project phase of construction of the new PFS13 line as well as day-to-day operation support of the existing three PFS lines
During the project phase the Clean Utilities Engineer will be a key player in the cross functional project team in charge of the design, construction, commissioning, qualification, start-up and operational readiness of all GMP Utilities
During the day-to-day operation, the Clean Utilities Engineer will be responsible for effectively, reliably and cost effectively operating the site’s GMP Utilities and ancillary systems associated within their facilities, maintaining all these systems in a state of compliance, in-control, and fit for use, capable of meeting all site needs
Lead investigations of any out of spec results to determine root cause and determine and implement appropriate CAPAs
Monitor utility systems and maintain KPI’s to ensure operational excellence, in compliance with regulatory and company requirements
Provide written instructions for the proper way to operate and maintain the equipment and process to assure that the system operates within the controlled parameters
Implement efficient and effective maintenance and reliability techniques
Apply problem solving skills by leading equipment failures troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of process issues
Provide customer consultation and notifications on issues that involve utilities areas assigned
Provide technical support as necessary to maintenance, and operations personnel
Support internal and external inspections and investigations (including Quality and HSE)
Maintain efficient communications with appropriate site customer groups
Proficiency with Trackwise, VeevaVault and CAPA systems
Experience with maintenance and computerized maintenance management systems (CMMS)
Qualification
Required
B.S. in Chemical or Mechanical Engineering
Minimum of 7 years of engineering experience in the pharmaceutical industry
Preferred
Proficiency with Trackwise, VeevaVault and CAPA systems
Experience with maintenance and computerized maintenance management systems (CMMS)
Company
Mentor Technical Group
Mentor Technical Group is a minority-owned business setting new standards for multidisciplinary compliance, technical, and engineering services.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Lydmarie Llorens
HR Business Partner and Compliance Manager
Neyshia Rivera, MA
Human Resources Business Partner
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