Pharma Utilities & Facilities Engineer - GMP & Cleanroom Lead

Guerbet; Raleigh (NC); Presencial; USD 110.000 - 140.000; Jornada completa

Descripción de la vacante

Guerbet seeks an experienced Utilities & Facilities Engineer to support clean utilities and plant utilities in a GMP-regulated pharma manufacturing environment. You will collaborate with maintenance, Quality, EHS, and Production to troubleshoot, maintain, and lead capital projects while driving continuous improvement and ALCOA data integrity.

The role emphasizes system reliability, regulatory compliance, and collaboration across cross-functional teams on site in a manufacturing setting.

Formación

• Bachelor’s Degree in Engineering (Mechanical, Electrical, Industrial, or related) required.
• Master’s Degree preferred.
• 5–10 years of utilities and facilities engineering in pharma/regulated environments.
• Experience with clean utilities, HVAC, and GMP compliance.
• Proven CAPA, change control, and compliance documentation experience.
• Strong GMP, FDA, ISO knowledge.
• Excellent analytical and organizational skills.
• Detail-oriented with ability to manage multiple priorities.

Responsabilidades

• Provide technical guidance to maintenance technicians and utility operators.
• Maintain and operate clean utilities (WFI, PW, RO, clean steam) and plant utilities (HVAC, boilers, compressed air).
• Lead maintenance strategies including PM optimization and reliability improvements.
• Define preventive and predictive maintenance requirements by system criticality.
• Support spare-parts strategies and lifecycle planning.
• Oversee cleanroom HVAC systems and environmental controls.
• Assist in deviations, investigations, and regulatory inspections.
• Lead project coordination with contractors and vendors to ensure GMP compliance.

Conocimientos

Analytical skills

Problem-solving

Communication

Leadership

Attention to detail

ALCOA data integrity

Microsoft Office

QMS

GMP compliance

Educación

Bachelor's Degree in Engineering

Master's Degree preferred

Herramientas

Microsoft Office

QMS

Descripción del empleo

Guerbet seeks an experienced Utilities & Facilities Engineer to support clean utilities and plant utilities in a GMP-regulated pharma manufacturing environment. You will collaborate with maintenance, Quality, EHS, and Production to troubleshoot, maintain, and lead capital projects while driving continuous improvement and ALCOA data integrity.

The role emphasizes system reliability, regulatory compliance, and collaboration across cross-functional teams on site in a manufacturing setting.