Sterile Facility Engineer: GMP, Cleanrooms & Utilities

Serovia USA Inc.; Branchburg Township (NJ); Sur place; USD 110 000 - 160 000; Plein temps

Résumé du poste

Serovia USA Inc. seeks a Facility Engineer to lead long-term operation and optimization of a sterile injectable IV bag manufacturing facility in New Jersey. You will drive improvements to cleanrooms, HVAC, utilities, and building automation, ensuring patient safety and regulatory compliance.

You will collaborate with Validation, Quality, and Operations to qualify systems (IQ/OQ/PQ) and implement preventive maintenance, risk assessments, and energy management to reduce operating costs.

Qualifications

• Bachelor’s degree in engineering with pharma/sterile manufacturing exposure.
• Strong knowledge of HVAC, cleanrooms, and critical utilities.
• Experience with cGMP, USP, EHS requirements.

Responsabilités

• Identify system improvements with costing, impact and timing; justify investments.
• Lead design reviews and technical oversight of sterilization utilities and systems.
• Develop and maintain facility engineering standards and specs.
• Oversee installation, commissioning, and qualification of utilities.
• Collaborate with Validation, Quality, and Operations for IQ/OQ/PQ readiness.
• Promote safety and perform risk assessments for engineering activities.
• Establish and manage maintenance programs and calibration schedules.
• Provide troubleshooting for deviations and CAPAs; ensure regulatory compliance.
• Partner with EHS, Operations, and Quality to meet expectations.
• Manage external firms and service providers for projects.
• Support energy management and sustainability initiatives.

Connaissances

Facility infra

HVAC systems

Regulatory compliance

Project management

Cross-functional collaboration

Root cause analysis

IQ/OQ/PQ readiness

Energy management

Formation

Bachelor’s in chemical, mechanical, or electrical engineering

Description du poste

Serovia USA Inc. seeks a Facility Engineer to lead long-term operation and optimization of a sterile injectable IV bag manufacturing facility in New Jersey. You will drive improvements to cleanrooms, HVAC, utilities, and building automation, ensuring patient safety and regulatory compliance.

You will collaborate with Validation, Quality, and Operations to qualify systems (IQ/OQ/PQ) and implement preventive maintenance, risk assessments, and energy management to reduce operating costs.