Clean Utilities Engineer (Regulated Industry)

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.
• Maintain 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)

Qualifications Requirements/Knowledge/Education/Skills

• B.S. in Chemical or Mechanical Engineering
• Minimum of 7 years of engineering experience in the pharmaceutical industry