Clean Utilities Engineer (Regulated Industry)

Mentor Technical Group•Concord, NC

About The Position

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America. 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. Objectives: 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.

Requirements

B.S. in Chemical or Mechanical Engineering
Minimum of 7 years of engineering experience in the pharmaceutical industry
Proficiency with Trackwise, VeevaVault and CAPA systems.
Experience with maintenance and computerized maintenance management systems (CMMS)

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.