Senior Facilities Engineer — Pharma Sterile Systems Lead

Amneal Pharmaceuticals; Town of Brookhaven (NY); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

401(k) matching

Health benefits

Job summary

Amneal Pharmaceuticals is seeking a Senior Facilities Engineer to lead construction, utilities, and equipment installation for a sterile facility. You will manage qualification activities, schedules, budgets, and resources to ensure compliant, reliable operations.

Responsibilities include leading FAT/IQ/OQ/PQ activities, developing validation plans, and maintaining preventive maintenance programs. You will also drive SOP updates, change control, CAPAs, and regulatory compliance across the site.

Qualifications

• Bachelor's degree in Engineering or related field is required.
• Master's degree in Engineering preferred.
• 5+ years in facilities management/engineering within pharma or life sciences with sterile/aseptic facilities is expected.

Responsibilities

• Lead facility infrastructure construction and utilities installation/upgrades projects with scopes, plans, budgets and risk assessments.
• Oversee qualification activities (FAT, IQ, OQ, PQ) and support validation master plan and EMPQ; manage requalification per schedule.
• Ensure facility infrastructure uptime; develop training materials; improve maintenance strategy and costs.
• Execute SOP updates and lead change controls; support root-cause investigations and CAPA.
• Ensure compliance with local regulatory requirements through monitoring and oversight.

Skills

cGMP knowledge

Project management

Problem solving

Communication

Engineering software

BEAM software

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Tools

BEAM software

Engineering software

Job description

Amneal Pharmaceuticals is seeking a Senior Facilities Engineer to lead construction, utilities, and equipment installation for a sterile facility. You will manage qualification activities, schedules, budgets, and resources to ensure compliant, reliable operations.

Responsibilities include leading FAT/IQ/OQ/PQ activities, developing validation plans, and maintaining preventive maintenance programs. You will also drive SOP updates, change control, CAPAs, and regulatory compliance across the site.