Senior Facilities Engineer — Sterile Systems & Projects Lead

Amneal Pharmaceuticals LLC; Town of Brookhaven (NY); Sur place; USD 110 000 - 125 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC is seeking a Senior Facilities Engineer to lead construction, utilities installation, and equipment qualification for a sterile facility. You will manage project timelines, budgets, and resources, while developing preventive maintenance and standardized troubleshooting procedures to maximize uptime.

You will oversee FAT/IQ/OQ/PQ activities, validate systems, and participate in CAPA investigations.

Qualifications

• 5+ years in facilities management, engineering, or related field within pharmaceutical or life sciences with sterile/aseptic facility.
• Strong understanding of cGMP, FDA regulations, and related standards.
• Proven project management and leadership skills.
• Excellent communication and interpersonal abilities for cross-team collaboration.
• Proficiency in relevant engineering software and tools including BEAM.

Responsabilités

• Lead facility infrastructure construction and utilities installation/upgrades projects with defined scopes, plans, budgets and timelines.
• Oversee qualification activities (FAT, IQ, OQ, PQ) for new constructions, utilities and equipment; support validation master plan and EMPQ.
• Maintain facility infrastructure and utilities, and lead maintenance strategy improvements.
• Develop and update SOPs; lead change control processes and CAPA investigations.
• Ensure compliance with local regulatory requirements through proactive monitoring and oversight.

Connaissances

Project management

Leadership

Communication

Problem solving

Regulatory collaboration

Formation

Bachelor’s degree in Engineering

Master’s degree in Engineering (preferred)

Outils

BEAM software

Description du poste

Amneal Pharmaceuticals LLC is seeking a Senior Facilities Engineer to lead construction, utilities installation, and equipment qualification for a sterile facility. You will manage project timelines, budgets, and resources, while developing preventive maintenance and standardized troubleshooting procedures to maximize uptime.

You will oversee FAT/IQ/OQ/PQ activities, validate systems, and participate in CAPA investigations.